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  • Development, Optimization and Comparative Evaluation of Diclofenac Sodium Sustained Release Matrix Tablets Using Polymers

  • 1, 2 Lords University,Alwar Bhiwadi Rd, Chikani, Rajasthan 301028

    3 Pavitra Institute of Pharmacy, Gurugram, Haryana 122102.

Abstract

The present study was aimed at the formulation and evaluation of sustained release matrix tablets of Diclofenac Sodium using different hydrophilic and hydrophobic polymers to achieve prolonged drug release, improve therapeutic efficacy, and enhance patient compliance. Diclofenac Sodium, a widely used non-steroidal anti-inflammatory drug (NSAID), possesses a short biological half-life and requires frequent administration, which may lead to poor patient adherence and gastrointestinal side effects. To overcome these limitations, sustained release matrix tablets were prepared using various grades of Hydroxypropyl Methylcellulose (HPMC K4M, HPMC K15M, and HPMC K100M) along with Ethylcellulose as release-retarding polymers. The tablets were formulated by wet granulation technique and evaluated for pre-compression and post-compression parameters including angle of repose, bulk density, tapped density, hardness, friability, weight variation, thickness, and drug content uniformity. Drug-excipient compatibility studies were carried out using FTIR and DSC analyses, which confirmed the absence of significant interactions between the drug and excipients. In-vitro dissolution studies were performed using USP type II paddle apparatus in phosphate buffer pH 6.8 for 12 hours. Among all formulations, batch F4 containing HPMC K15M and Ethylcellulose exhibited the most desirable sustained release profile with 92% drug release over 12 hours, acceptable mechanical strength, and minimal burst release. Release kinetics studies indicated that the optimized formulation followed near zero-order kinetics, demonstrating controlled and concentration-independent drug release. Comparative dissolution studies with marketed formulation (Voveran SR) revealed similar release behavior. The study concluded that the developed sustained release matrix tablet of Diclofenac Sodium can serve as a promising alternative to conventional dosage forms for prolonged therapeutic action and improved patient compliance

Keywords

Diclofenac Sodium; Sustained Release Matrix Tablet; HPMC; Ethylcellulose; Wet Granulation; Controlled Drug Delivery; In-vitro Dissolution Study; Release Kinetics; FTIR; DSC

Introduction

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The kinetics of Drug release is divided into three parts: immediate release (IR), modified release (MR), and specialized forms (1). IR tablets breakdown quickly (within 15-30 minutes), delivering the complete dose for immediate absorption-ideal for acute situations but prone to plasma peaks. MR tablets, which include Sustained Release (SR) (2), Controlled Release (CR), and Extended Release (ER), regulate release to improve bioavailability, reduce dose frequency, and reduce side effects such as gastrointestinal. Among the most common and adaptable solid unit dosage form used in pharmaceutical sciences are Tablets, consisting of powdered medicinal ingredients and excipients crushed into compact, discoid shapes for oral administration. Manufacturing Methods (3).

  1. Direct compression: Pre-blended granules compressed directly into tablets, making the process very fast, simple and cost-effective. Direct compression is a tablet manufacturing method where active pharmaceutical ingredients (API) and excipients are blended and compressed directly into tablets without granulation steps (4). Process Steps includes:
  1. API blended with fillers (e.g., lactose, microcrystalline cellulose) for uniformity of tablets.
  2. Then add lubricants or glidant (e.g., magnesium stearate) and disintegrates.
  3.  Finally compress the granules using rotary presses with induced die feeders to aid powder flow and reduce air entrapment.

 Advantages

  1. Fewer unit operations, no moisture/heat, cutting time and costs.
  2. Faster dissolution and better stability than wet granulation.
  3. Ideal for heat-sensitive drugs and SR matrices like HPMC-based systems (5).

Limitations

  1. High-dose APIs may segregate; low-dose needs uniform blending. Requires flowable excipients
  1. Wet granulation: It is a tablet manufacturing process that help to improves the powder flow, compressibility, and content uniformity by forming granules with a liquid binder before compression (6). The Process are as follows-
  1. Mix API or excipients, for preparing binder solution (e.g., PVP in water).
  2. Form wet mass by adding binder; screen the granules using sieve.
  3. Dry the granules in oven or fluidized bed dryer, resize the granules, then lubricate them before tableting.

 Advantages

  1. Better for poor-flow APIs; enhances density and reduces segregation in SR matrices (7).

  Limitations

  1. Introduces moisture/heat risks; more steps increase time/cost compared to DC.
  1. Dry granulation: It is also called slugging or roller compaction, is a tablet manufacturing technique that densifies powder blends into granules without liquids or heat, ideal for moisture/heat-sensitive APIs like those in SR matrices (8). Process Steps
  1. Blend API or excipients, and add some amount of lubricant for flow of powders.
  2. Compact via slugging (press into large slugs) or roller compaction (rollers form ribbons).
  3. Mill/size slugs/ribbons, add remaining lubricant or disintegrates, then compress into tablets.

Advantages

  1. No moisture avoids hydrolysis; fewer steps than wet but more than direct compression; good for poor-flow powders in SR formulations.

Limitations

  1. Requires cohesive materials; potential over-compression fines; less uniform than wet for some APIs

TYPES OF TABLET ON THE BASIS OF RELEASE PROFILE

  1. Immediate Release (IR) Disintegration + dissolution         Rapid onset; full dose in 30-60 min (9).
  2. Sustained Release (SR)         Prolonged release over 4-8 hours       Reduces peaks/troughs, improves compliance Matrix tablets for NSAIDs; maintains steady analgesia (10).
  3. Controlled Release (CR)      Zero-order kinetics; predictable rate  Constant plasma levels; diffusion or erosion-based, ideal for chronic therapy (11).
  4. Extended Release (ER)         Provides prolonged drug release for 8-24 hours, allowing once- or twice-daily dosing. This improves patient convenience, enhances compliance, and maintains more stable therapeutic drug levels. (12).

INTRODUCTION TO DRUG - DICLOFENAC SODIUM

    1. Tablets in Pharmaceutical Dosage Forms

Pharmaceutical dose forms provide the safe, effective, and convenient delivery of medications. Tablets are among the most popular solid oral forms due to their precise dose, stability, cost-effectiveness, and patient acceptance (3). They are made up of powdered drugs and excipients compressed into a compact unit, making oral administration the preferred method due to its ease, large surface area in the gastrointestinal tract (GIT), and economic feasibility (13). Tablets mitigate the drawbacks of liquid forms, such as volatility and dosage mistakes, while also enabling modified-release patterns. This study focuses solely on tablet kinds, specifically sustained release, controlled release, and extended release versions.

 

 

IUPAC Name: sodium 2-[2-(2,6-dichloroanilino) phenyl] acetate (14)

Among the most frequently prescribed preparations because of their outstanding analgesic, and antipyretic effects. Between 1875 and 1940, only salicylic acid derivatives were used as non-steroidal anti-inflammatory drugs. The number of new drugs and the marketing of NSAIDs have dynamically increased in the past four decades. To-day more than 100 preparations are on the market or under clinical investigation.

Table no.1 Properties of Diclofenac Sodium (PubChem)

Molecular Weight

318.1 g/mol

Hydrogen Bond Donor Count

1

Hydrogen Bond Acceptor Count

3

Heavy Atom Count

20

 

    1. Need for Sustained release tablet- Many drugs need to stay within a specific concentration range in the blood to be effective (15). A sustained-release design helps-
  2. Avoid peaks (too high concentration → side effects)
  3. Prevent troughs (too low concentration → loss of effect)
      1. Reduced Dosing Frequency- Immediate-release drugs often require multiple doses per day. SR tablets allow:
  1. Once- or twice-daily dosing
  2. Better patient convenience
  3. Improved medication compliance
      1. Lower Side Effects- By avoiding high peak drug levels, sustained release:
  1. Reduces peak-related adverse effects
  2. Decreases irritation at the site of absorption (e.g., stomach) (16)
    1. Improved Patient Adherence- Simpler dosing schedules help patients stick to their treatment:
  1. Less frequent dosing
  2. Easier to remember
  3. Better long-term therapy outcomes
    1. Targeted Therapeutic Action- Some drugs benefit from sustained action at a specific site, such as gut or systemic circulation, leading to:
  1. More consistent symptom control
  2. Better quality of life (e.g., pain relief, blood pressure control)
    1.        Objectives of oral Sustained- release matrix tablet
  1. To maintain a constant and therapeutically effective drug concentration in the body for a specified period of time.
  2. To reduce dosing frequency compared to conventional dosage forms, by improving patient compliance
  3. To deliver the drug directly to the site of action, which minimize exposure to non- target tissues and reducing side effects.
  4. This may necessitate targeting specific receptors or localization to specific cells or body regions.
  5. To enhance the safety margin of potent drugs by controlling their release and distribution
  6. To reduce the incidence of local and systemic adverse effects, especially in sensitive population of patient.
    1. ADVANTAGES
  1. Reduced dosing frequency, leading to more convenient therapy.
  2.  Minimization of Side effects by avoiding fluctuations in drug concentration.
  3. Drug release that is consistent and controlled over an extended period of time.
  4.  Improved patient compliance due to simplified dosing schedules.
    1. DISADVANTAGES
  1. It does not allow for a quick end to therapy
  2.  Dose change versatility is restricted.
  3. The average biological half-life is used to design these dosage types.
  4.  They are pricey.

 

 

 

Table 2 Summary of Literature on Diclofenac Sodium sustained release formulations:

Search engines used are as below:

 

Serial Number

Search engine

References

1

PubMed

https://pubmed.ncbi.nlm.nih.gov/

2

Scopus

https://www.scopus.com/sources.uri

3

Embase

https://www.elsevier.com/en-in/products/embase

4

Google Scholar

https://scholar.google.com/

5

Pharmacopoeias

https://iponline.ipc.gov.in/jspui/

MATERIALS AND METHODS

Diclofenac Sodium was obtained from CDH fine chemicals, HPMC grades K4M, K15M and K100M were received from Pavitra College of Pharmacy. Ethylcellulose was used as a hydrophobic Polymer. Microcrystalline cellulose (MCC, Avicel PH 102), was used as a diluent. Magnesium Stearate and talc were used as lubricant and glidant, respectively (23). All chemicals and reagents used were of analytical grade.

PHASE 2: PREFORMULATION STUDIES

Physicochemical Studies

Organoleptic Properties: Diclofenac Sodium was examined for its physical appearance, colour, odour, and taste.

Table 3 Organoleptic properties of Diclofenac sodium

Sl. No.

Parameter

Observation

1

Colour

White to slightly off white

2

Odour

Odourless

3

Appearance

Crystalline powder

4

Texture

Fine, free-flowing powder

 

5

Taste

Bitter

These observations were found to be consistent with standard pharmacopoeial specifications.

5.1. Melting Point: The melting point of Diclofenac Sodium was determined using the capillary tube method, the reported melting point range for Diclofenac Sodium is 275-290°C (24) and the Observed melting point was found to be 285°C. The sharp melting point indicates the purity and crystalline nature of the drug.

    1.  Solubility Studies: Solubility studies were carried out in different media to understand the drug’s solubility behavior at physiological pH conditions.

Medium

Solubility

Distilled Water

Practically soluble

pH 1.2 buffer

Slightly soluble

pH 6.8 buffer

Sparingly soluble

pH   7.4 buffer

Freely soluble

The results confirm that Diclofenac Sodium exhibits pH-dependent solubility, which supports the need for sustained release formulation.

    1. Partition Coefficient: The partition coefficient (log P) was determined using the n-octanol and water system. Log P value was found to be ~4.5. A high partition coefficient indicates the lipophilic nature of Diclofenac Sodium, which contributes to its prolonged biological half-life and suitability for sustained release dosage forms.
    2. Determination of λmax: A solution of Diclofenac Sodium was scanned in the UV range (200-400 nm) using a UV-Visible spectrophotometer. The UV absorption spectrum of Diclofenac Sodium was recorded to determine the wavelength of maximum absorbance (λmax). A suitably diluted solution of Diclofenac Sodium was prepared using phosphate buffer pH 6.8 and scanned in the wavelength range of 200-400 nm using a UV-Visible spectrophotometer against the same buffer as blank. The UV spectrum showed a distinct and sharp absorption peak at 276 nm, which corresponds to the λmax of Diclofenac Sodium. This wavelength was selected for further quantitative estimation of the drug in calibration curve preparation, drug content analysis, and in vitro dissolution studies.

 

 

 

 

The sharp peak and absence of interference from the solvent indicate the suitability of the method for accurate drug estimation. λmax of Diclofenac Sodium: 276 nm

Compatibility Studies

    1. Compatibility studies were carried out to evaluate the physicochemical interaction between Diclofenac Sodium and selected excipients in the formulation of sustained-release matrix tablets. Drug-excipient compatibility is essential to ensure formulation stability, efficacy, and safety throughout the product’s shelf life. Preparation of Physical Mixtures: Physical mixtures of Diclofenac Sodium with individual excipients (HPMC K4M, HPMC K15M, HPMC K100M, Ethylcellulose, and MCC) were prepared in a 1:1 ratio by gentle trituration to ensure uniform mixing. The mixtures were stored in airtight containers until analysis.
    2. Fourier Transform Infrared Spectroscopy (FTIR) FTIR analysis was carried out over the spectral range of 4000–400 cm⁻¹ to investigate any potential chemical interactions between Diclofenac Sodium and the selected excipients, namely MCC, HPMC, and Ethylcellulose. The study was conducted to assess the compatibility of the drug with formulation excipients. FTIR spectroscopy is widely used for:
  2. Identification of characteristic functional groups of the drug molecule
  3. Detection of possible drug-excipient interactions
  4. Evaluation of the chemical stability of the formulation components.

The FTIR spectrum of pure Diclofenac Sodium was recorded and compared with the spectra obtained from its physical mixtures with the selected excipients.

 

 

 

 

The FTIR spectrum of pure Diclofenac Sodium showed characteristic absorption bands at:

  1. ~3323 cm⁻¹ → N–H / O-H stretching
  2. 2920–2850 cm⁻¹ → C-H stretching
  3. ~1708 cm⁻¹ → C=O stretching (carboxyl group)
  4. 1600–1500 cm⁻¹ → Aromatic C=C stretching
  5. 1200–1000 cm⁻¹ → C-O stretching

These peaks confirm the identity of Diclofenac Sodium.

FTIR of Drug-Excipient Mixture The physical mixtures of Diclofenac Sodium with:

  1. MCC
  2. HPMC K4M / K15M
  3. Ethylcellulose, were analyzed.

RESULT- It was observed that:

  1. All major characteristic peaks of Diclofenac Sodium were retained.
  2. No significant peak shift was observed.
  3. No disappearance of functional group peaks occurred.
  4. No additional new peaks were detected.

Minor variations in intensity were observed, which may be attributed to physical mixing and hydrogen bonding interactions, but not chemical interaction. The absence of:

  1. Significant peak shifting
  2. Peak broadening beyond normal range
  3. New peak formation, indicates that there is no chemical interaction between Diclofenac Sodium and the selected excipients. Thus, the excipients used are compatible with the drug.
    1. Differential Scanning Calorimetry (DSC) was carried out to study the thermal behaviour of Diclofenac Sodium and to evaluate possible drug-excipient interactions. Accurately weighed samples (approximately 3-5 mg) of pure Diclofenac Sodium and drug-excipient physical mixtures (1:1 ratio) were placed in aluminum DSC pans and sealed. An empty sealed aluminum pan was used as a reference

 

 

 

 

 

 

 

 

The analysis was performed using a calibrated DSC instrument under a nitrogen atmosphere to avoid oxidative degradation. The samples were heated over a temperature range of 50-300 °C at a constant heating rate of 10 °C/min (25). The heat flow was recorded as a function of temperature, and the resulting thermograms were analyzed. The DSC thermograms of the physical mixtures were compared with that of pure Diclofenac Sodium to observe any changes in the melting endotherm, peak temperature, or peak shape. The presence or absence of peak shifting, disappearance, or formation of new peaks was used to assess drug-excipient compatibility.

Results- The DSC thermograms of pure Diclofenac Sodium exhibited a sharp and well-defined endothermic peak at approximately 284°C, corresponding to its melting point. The sharp nature of the peak indicates the crystalline character and purity of the drug. The DSC thermograms of the physical mixtures (1:1) of Diclofenac Sodium with HPMC K4M, HPMC K15M, HPMC K100M, Ethylcellulose, and MCC showed the presence of the characteristic melting endotherm of the drug with slight reduction in peak intensity. The decrease in peak intensity can be attributed to the dilution effect of excipients in the physical mixtures. Importantly, no significant shift in the melting temperature, disappearance of the endothermic peak, or appearance of new peaks was observed in any of the thermograms. This indicates the absence of chemical interaction or incompatibility between Diclofenac Sodium and the selected excipients. Minor broadening of peaks observed in some mixtures may be due to physical mixing or overlapping thermal events of polymers; however, these changes were not significant enough to suggest interactio                                                          

FORMULATION DEVELOPMENT

Formulation Design Explanation: The drug content was kept constant at 100 mg in all formulations of Diclofenac sodium sustained release matrix tablet. Different grades of HPMC were used to study the effect of polymer viscosity on drug release profile.

  1. HPMC K4M (low viscosity) in F1-F3
  2. HPMC K15M (medium viscosity) in F4-F5
  3. HPMC K100M (high viscosity) in F6

Ethylcellulose was incorporated in selected two batches (F3-F5) to enhance matrix retardation and control drug release. MCC (Avicel PH 102) was used as diluent and filler to maintain constant tablet weight (300 mg). Magnesium stearate (1%) served as lubricant for the tablet. Talc acted as glidant to improve its flowability.

 

 

 

 

 

Table 4: Formulation of Diclofenac Sodium Sustain Released Matrix Tablet

Ingredients

F1

F2

F3

F4

F5

F6

Diclofenac Sodium

100

100

100

100

100

100

HPMC K4M

45

60

75

-

-

-

HPMC K15M

-

-

-

60

75

-

HPMC K100M

-

-

-

-

-

90

Ethylcellulose

-

-

15

15

15

-

MCC (Avicel PH 102)

142

127

97

112

97

97

Magnesium Stearate

3

3

3

3

3

3

Talc

10

10

10

10

10

10

Total Weight (mg)

300

300

300

300

300

300

 

  1. Evaluation of Flow Properties (Pre-Compression Parameters) The flow properties of the powder blends were evaluated prior to compression to ensure uniform die filling and consistent tablet weight. The following parameters were determined:
      1. Angle of Repose (θ) The angle of repose was determined by the fixed funnel method. The powder blend was allowed to flow through a funnel onto a flat surface to form a conical heap. The height (h) and radius (r) of the heap were measured, and the angle of repose was calculated.

tanθ=hr

 

 

 

Sl. no

     Angle of Repose (°)

              Flow Property

 

1

            < 25     

                Excellent

 

2

            25–30   

                   Good

3

            30–40

                Passable

4

            > 40     

                   Poor

 

      1. Bulk Density and Tapped Density an accurately weighed quantity of powder blend was poured into a graduated measuring cylinder to measure bulk volume. The cylinder was then tapped mechanically until a constant volume was obtained to determine tapped volume.

Bulk Density(ρb)=MassBulk volume

 

 

Tapped density ρt=MassTapped Volume

 

      1. Carr’s Compressibility Index

Carr’s Index was calculated from bulk and tapped densities to assess compressibility and flow.

Carr's Index%=ρt​-ρbρt​ ×100

 

      1.  Hausner’s ratio is another indicator of powder flowability The Hausner ratio is calculated by dividing the tapped density of a powder by its bulk density. It is a dimensionless metric used to assess the flowability of powders and granules, where a lower ratio typically indicates better flow, while higher values indicate increased cohesive behaviour.

        

 

Table 5. Pre-Compression Flow Properties of Diclofenac Sodium Powder

Formulation

 

Angle of Repose (°)

Bulk Density (g/cm³)

Tapped Density (g/cm³)

Carr’s Index (%)

Hausner’s Ratio

F1

27.5

0.45

0.52

13.4

1.15

F2

26.8

0.46

0.53

13.2

1.15

F3

28.2

0.44

0.51

13.7

1.16

F4

27.1

0.47

0.54

12.9

1.14

F5

29.0

0.43

0.50

14.0

1.16

F6

28.5

0.45

0.52

13.5

1.21

 

Results & Discussion All powder blends exhibited good to fair flow properties, as indicated by angle of repose values below 35°, Carr’s index below 20%, and Hausner’s ratio less than 1.25. Slightly higher values observed in formulations containing higher viscosity HPMC may be attributed to increased cohesiveness of the polymer. Overall, the flow characteristics were found to be suitable for tablet preparation by the direct compression method.

WET GRANULATION Sustained-release matrix tablets of Diclofenac sodium were prepared by the wet granulation method. Accurately weighed quantities of drug, polymer, ethylcellulose, and MCC were passed through sieve 44 and blended uniformly. The powder blend was granulated using isopropyl alcohol containing PVP K30 as binder. The wet mass was passed through sieve 16 and dried at 45°C for 30-40 min until the granules dried. Dried granules were resized, lubricated with magnesium stearate and talc, and compressed into tablets of 300 mg using a rotary tablet compression machine.

 

 

 

 

 

 

 

 

 

 

    1. Post-Compression Evaluation of Diclofenac Sodium Matrix Tablets (F1-F6)

After compression, all batches (F1-F6) were evaluated for official post-compression quality control parameters to ensure mechanical strength, uniformity, and performance of sustained-release tablets.

General Appearance Tablets were visually inspected for- Colour uniformity, Surface smoothness Absence of cracks, capping, lamination, or mottling. All batches were found to be circular, flat-faced, and free from visible defects.         

  1. Thickness
  1. Measured using a Vernier calliper
  2. Average of three tablets was recorded
  3. Uniform thickness indicates consistent die fill and compression force.

Table 6 Thickness of Diclofenac Sodium sustained release matrix tablet

Formulation

Thickness (mm) (Mean ± SD)

F1

3.42 ± 0.05

F2

3.48 ± 0.04

F3

3.50 ± 0.06

F4

3.46 ± 0.03

F5

3.52 ± 0.05

F6

3.58 ± 0.04

All tablets showed uniform thickness indicating consistent die filling and compression force.

  1. Weight Variation Test

Twenty tablets from each batch were weighed individually and the average weight was calculated. Since tablet weight is 300 mg, the acceptable pharmacopoeial limit (IP/USP) is: ±5% deviation (for tablets ≥250 mg)

 

Table 7 Weight variation of Diclofenac Sodium sustained release matrix tablets

Formulation

Average weight (mg)

% Deviation

Result

F1

298 ± 2.1

0.67%

Pass

F2

301 ± 1.8

0.33%

Pass

F3

299 ± 2.5

0.34%

Pass

F4

300 ± 1.6

0.00%

Pass

F5

302 ± 2.0

0.66%

Pass

F6

297 ± 2.3

1.00%

Pass

 

All formulations complied with the specified limits.

  1. Hardness (Crushing Strength)
  • Determined using a Monsanto.
  • Ideal range for matrix tablets: 5-8 kg/cm²

Table 8 Hardness of Diclofenac sodium sustained release matrix tablet

Formulation

Hardness (kg/cm²) (Mean ± SD)

F1

5.5 ± 0.2

F2

5.8 ± 0.3

F3

6.0 ± 0.2

F4

6.5 ± 0.3

F5

6.8 ± 0.2

F6

7.2 ± 0.3

Adequate hardness ensures mechanical stability without affecting drug release.

  1. FRIABILITY The friability test of all the batches of tablets were determined by using Roche friabilator at 25 rpm, 100 revolutions. Limit: < 1%

Table 9 Friability of Diclofenac sustained release matrix tablets

Formulation

Friability (%)

Result

F1

0.78

Pass

F2

0.72

Pass

F3

0.65

Pass

F4

0.58

Pass

F5

0.50

Pass

F6

0.42

Pass
  1. Drug Content Uniformity is analyzed at λmax 276 nm using UV-Visible Spectrophotometer and the acceptable range is 95-105%

Table 10 Drug content Uniformity of Diclofenac Sodium sustained release matrix tablet

Formulation

Drug Content (%) (Mean ± SD

F1

97.2 ± 1.2

F2

98.4 ± 1.0

F3

99.1 ± 0.9

F4

100.3 ± 1.1

F5

101.4 ± 0.8

F6

98.9 ± 1.3

All formulations showed uniform drug distribution

In-Vitro Dissolution Study

  • Apparatus: USP Type II (Paddle)
  • Dissolution medium: 900 mL Phosphate buffer (pH 6.8)
  • Temperature: 37 ± 0.5°C
  • Rotation speed: 50 rpm
  • Sampling intervals: 1, 2, 4, 6, 8, 10, and 12 hours
  • Marketed formulation for Comparison: Voveran SR

The samples were filtered, diluted appropriately, and analyzed by spectrophotometer. The cumulative percentage drug release was calculated.

  1. K4M → faster release
  2. K15M → moderate
  3. K100M → slowest

 

Table 11. Drug release Profile of formulations (F1-F6). F1, F2, F3, F4, F5, F6 + Voveran SR

Time

F1

F2

F3

F4

F5

F6

Marketed formulation(comparison)

1hour

22

18

15

14

12

10

1

2 hour

35

30

26

24

22

18

2

4 hour

55

48

42

40

35

30

21

6 hour

70

63

58

54

50

45

43

8 hour

85

78

72

68

63

58

62

10 hour

95

90

85

82

78

72

78

12 hour

99

97

94

92

89

85

88

 

In SR matrix tablets, early sampling at 1-2 hour intervals is essential to monitor initial burst release, lag phase, early gel formation (e.g., HPMC swelling), and to confirm the tablet does not accidentally behave like an IR formulation. These rapid early changes require closer intervals to detect risks like dose dumping.

Later Phase Sampling- After 2 hours, the matrix stabilizes as the gel layer fully forms, making drug release diffusion-controlled with predictable, steady diffusion paths, so 2-hour intervals suffice.(26)

Core Release Mechanisms

  1. Initial burst: Quick surface drug dissolution, often mitigated by polymer coatings (27).
  2. Gel layer role: Swells to create a barrier, transitioning from hydration-driven to erosion/diffusion kinetics.
  3. Stabilization benefit: Ensures reliable monitoring post-initial phase without excessive sampling.

Based on Drug Release Profile at final time 12-hour release:

  1. F1 → 99% (shows too fast, almost like the immediate release)
  2. F2 → 97% (slightly fast as compared to others batches)
  3. F3 → 94%
  4. F4 → 92%
  5. F5 → 89%
  6. F6 → 85% (too slow → incomplete release)

Ideal SR tablet should release approximately between 85-5% drug in 12 hours to avoid burst release and should not release too slowly here the batch F4 shows - No burst effect only 14% at 1 hr, controlled gradual release and 92% at 12 hr (within ideal range). Therefore, F4 shows balanced release.

Based on Polymer Composition the F4 batch contains:

  1. HPMC K15M (60 mg) → medium viscosity
  2. Ethylcellulose (15 mg) → hydrophobic retardant
  3. K4M (low viscosity) → faster release
  4. K100M (high viscosity) → excessive retardation
  5. K15M → balanced gel formation

So, F4 provides Controlled gel, strength proper, swelling stable and diffusion barrier.

Based on Mechanical Properties the formulation F4 shows:

  1. Hardness: 6.5 kg/cm² (ideal for SR tablet)
  2. Friability: 0.58% (within limit)
  3. Drug content: 100.3% (excellent)

The thickness was uniform so; it is mechanically stable. F4 was selected based on its controlled and gradual drug release profile extending up to 12 hours (92%), absence of burst release, acceptable mechanical strength, uniform drug content, and balanced polymer composition. Compared to other formulations, F4 provided optimal sustained release without excessive retardation or rapid release, making it the most suitable formulation.

 

 

 

 

​                              Figure 7: Drug release kinetics of formulations (F1-F6)

 

  1. Zero-order kinetics calculation for F4

Zero-order equation:

Qt=K0​t +C

 

Where,

Qt = % drug released at time t

K0 = zero-order release constant

T = time (hr)

C = intercept

Zero- order slope

K0=NXY-(X)(Y)NX2-(X2)

 

Table 12. Zero- order kinetics release of formulation F4

X (Time)

Y( %Release)

XY

X2

1

14

14

1

2

24

48

4

4

40

160

16

6

54

324

36

8

68

544

64

10

82

820

100

12

92

1104

144

Where summations,

X

 = 43, X=374
, XY=3014
, ∑X2=365
, N=7

 

        = (7×3014) – (43×374)

                   = 5016

 

 

 

Figure 8 Zero-order kinetics of F4

 

  1. First order kinetics for F4 formulation

log(100−Qt​)

Where, Qt = % drug released at time t

 

 

 

Table 13 First order kinetics release of formulation F4

Time (Hour)

% Drug Released (Qt)

% Drug Remaining (100−Qt)

log (100−Qt)

1

14

86

1.934

2

24

76

1.880

4

40

60

1.778

6

54

46

1.663

8

68

32

1.505

10

82

18

1.255

12

92

8

0.903

 

 

 

Figure 9 First- order Kinetics of F4

 

ANOVA-ONE WAY

Table

 

14 Mean drug release and SD of Formulation (F1-F6)

Formulation

Mean drug release(%)

SD

F1

60.33

1.15

F2

54.50

1.15

F3

49.67

0.58

F4

47.00

1.00

F5

42.83

0.58

F6

38.50

1.15

 

 

 

 

 

 

 

One-way ANOVA was employed to determine whether there were statistically significant differences in the drug release profiles among the developed formulations. The analysis indicated significant variation in cumulative percentage drug release across the formulations, suggesting that the formulation variables such as polymer concentration and matrix composition had a pronounced effect on dissolution behavior. The calculated p-value (p < 0.05) was found to be less than 0.05, which confirms that the differences in drug release among the formulations were statistically significant at the 95% confidence level. This implies that the observed variations in release pattern were not due to random experimental error but were associated with formulation design.

The statistical outcome supports the dissolution study results and demonstrates that optimization of formulation parameters was essential for achieving controlled and sustained drug release. Among all the formulations, the optimized batch exhibited the most desirable release characteristics, further validating the effectiveness of the formulation strategy adopted in this study.

COMPARATIVE DISSOLUTION STUDY WITH MARKETED PREPARATION

Commercially available sustained release Diclofenac Sodium tablet marketed under the brand name Voveran SR 100 was selected as reference marketed formulation for comparative evaluation with the optimized laboratory formulations. Comparative dissolution analysis was performed in phosphate buffer pH 6.8 for 12 hours under identical USP type II conditions. Among all prepared batches, formulation F5 and F6 demonstrated dissolution profiles nearest to the marketed brand. F5 showed controlled initial hydration with gradual drug diffusion, whereas F6 exhibited maximum release retardation due to the presence of high viscosity HPMC K100M. The cumulative percentage drug release of Voveran SR 100 at 12 h was found to be approximately comparable with F5, indicating that the optimized formulation successfully mimics the release behavior of the commercial sustained release product. This comparative study confirms the industrial feasibility and market acceptability of the developed matrix tablet and suggests that formulation F5 may be considered as the optimized formulation due to its similarity with marketed sustained release Diclofenac preparation.

DISCUSSION

The present study was designed to develop and evaluate a controlled release formulation and to understand the drug release kinetics using in-vitro dissolution analysis. The formulation variables significantly influenced the release behavior, indicating that polymer concentration and matrix structure play a critical role in modulating drug diffusion and dissolution rate. Among all six prepared formulations, F1 to F3 containing lower concentration HPMC K4M showed comparatively faster drug release due to weaker gel barrier formation. F5 containing HPMC K15M with Ethylcellulose demonstrated improved matrix integrity and prolonged release. Formulation F4 provided the most desirable sustained release pattern extending up to 12 hours with acceptable pre-compression and post-compression characteristics. Although F6 containing HPMC K100M exhibited highest retardation, the release was comparatively slower than the marketed requirement. Therefore, F4 was considered as the optimized batch showing best balance between sustained release, matrix stability and comparative dissolution similarity.

Kinetic modelling of the dissolution data revealed that the release pattern was best approximated by the zero-order kinetic model, indicating a nearly constant drug release rate independent of drug concentration. Comparison with the first-order model suggested that drug release was not primarily concentration dependent. Statistical evaluation using one-way ANOVA confirmed that the differences in drug release among formulations were statistically significant, highlighting the impact of formulation optimization on dissolution performance. Overall, the study successfully developed an optimized controlled release formulation with improved release characteristics. Although formulation F6 exhibited a slower drug release profile similar to the initial phase of the marketed formulation Voveran SR, it showed excessive retardation and incomplete drug release over the study period. In contrast, formulation F4 demonstrated a balanced and controlled drug release pattern, achieving complete release within 12 hours and closely resembling the overall release profile of the marketed product. Therefore, F4 was considered the optimized formulation. The findings suggest that appropriate selection and optimization of formulation components can effectively modulate drug release behavior, which may enhance therapeutic efficacy and potentially reduce dosing frequency. Further in-vivo studies and stability evaluation may be carried out to confirm the clinical applicability of the developed system.

CONCLUSION

Among all formulations, F4 was identified as the optimized formulation. The formulations were ranked as: F4 > F5 > F3 > F2 > F1 > F6. The optimized formulation F4 was compared with Voveran SR and showed similar release behavior. Thus, formulation F4 was selected as the optimized sustained release matrix tablet of diclofenac sodium due to its controlled drug release, absence of burst effect, and close resemblance to the marketed formulation. The developed sustained release matrix tablet of diclofenac sodium can be considered a promising alternative to conventional dosage forms for improved therapeutic efficacy and patient compliance.

REFERENCES

    1. Fell JT, Newton JM. Determination of Tablet Strength by the Diametral-Compression Test. J Pharm Sci. 1970 May 1;59(5):688–91. doi:10.1002/jps.2600590523
    2. Colombo P, Bettini R, Santi P, De Ascentiis A, Peppas NA. Analysis of the swelling and release mechanisms from drug delivery systems with emphasis on drug solubility and water transport. J Controlled Release. 1996 May 1;Proceedings of the Seventh International Symposium on Recent Advances in Drug Delivery Systems39(2):231–7. doi:10.1016/0168-3659(95)00158-1
    3. Alqahtani MS, Kazi M, Alsenaidy MA, Ahmad MZ. Advances in Oral Drug Delivery. Front Pharmacol. 2021 Feb 19;12:618411. doi:10.3389/fphar.2021.618411 PubMed PMID: 33679401; PubMed Central PMCID: PMC7933596.
    4. Lin L, Wong H. Predicting Oral Drug Absorption: Mini Review on Physiologically-Based Pharmacokinetic Models. Pharmaceutics. 2017 Sep 26;9(4):41. doi:10.3390/pharmaceutics9040041 PubMed PMID: 28954416; PubMed Central PMCID: PMC5750647.
    5. Fuhrman LC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 8th Edition. Am J Pharm Educ. 2006 Jun 15;70(3):71. PubMed PMID: null; PubMed Central PMCID: PMC1636965.
    6. Aulton’s Pharmaceutics [Internet]. [cited 2026 May 6]. Available from: https://elsevier-elibrary.com/contents/fullcontent/58070/epubcontent_v2/OEBPS/xhtml/CHP031.html
    7. Sugandini G, Reddy MS. An Overview on Classification, Mechanism of Extended Release Drug Delivery of Oral Formulations. J Drug Discov Ther. 2023 Jun 28;11(3):06–17. doi:10.32553/jddt.v11i3.472
    8. Khobragade DS, Agrawal SS, Potbhare MS. Pharmacokinetic Considerations for Controlledrelease Dosage Forms. In: Novel Drug Delivery Systems (Part 1) [Internet]. Bentham Science Publishers; 2024 [cited 2026 May 6]. p. 39–86. Available from: https://www.benthamdirect.com/content/books/9789815274165.chapter-2
    9. 066c837e42600d_Ch-1_DK Tripathi - Drug Delivery Systems.pdf [Internet]. [cited 2026 May 6]. Available from: https://bspublications.net/downloads/066c837e42600d_Ch-1_DK%20Tripathi%20-%20Drug%20Delivery%20Systems.pdf
    10. Adepu S, Ramakrishna S. Controlled Drug Delivery Systems: Current Status and Future Directions. Molecules. 2021 Sep 29;26(19):5905. doi:10.3390/molecules26195905 PubMed PMID: 34641447; PubMed Central PMCID: PMC8512302.
    11. Choudhary A. Sustained Release and Prolonged Release Tablets and their Difference [Internet]. [cited 2026 May 6]. Available from: https://www.pharmaguideline.com/2018/01/difference-between-sustained-prolonged-release-tablets.html
    12. Efentakis M, Peponaki C. Formulation Study and Evaluation of Matrix and Three-layer Tablet Sustained Drug Delivery Systems Based on Carbopols with Isosorbite Mononitrate. AAPS PharmSciTech. 2008 Aug 7;9(3):917–23. doi:10.1208/s12249-008-9084-2 PubMed PMID: 18686040; PubMed Central PMCID: PMC2977044.
    13. Merchant HA, Babar ZUD, Hussain IM. A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies. J Pharm Policy Pract. 2022 Dec 22;15:104. doi:10.1186/s40545-022-00501-4 PubMed PMID: 36550588; PubMed Central PMCID: PMC9773520.
    14. Sohail Arshad M, Zafar S, Yousef B, Alyassin Y, Ali R, AlAsiri A, et al. A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing. Adv Drug Deliv Rev. 2021 Nov 1;178:113840. doi:10.1016/j.addr.2021.113840
    15. Suzuki Y, Sugiyama H, Kano M, Shimono R, Shimada G, Furukawa R, et al. Control strategy and methods for continuous direct compression processes. Asian J Pharm Sci. 2021 Mar;16(2):253–62. doi:10.1016/j.ajps.2020.11.005 PubMed PMID: 33995618; PubMed Central PMCID: PMC8105518.
    16. Chen H, Aburub A, Sun CC. Direct Compression Tablet Containing 99% Active Ingredient—A Tale of Spherical Crystallization. J Pharm Sci. 2019 Apr 1;108(4):1396–400. doi:10.1016/j.xphs.2018.11.015
    17. Denduyver P, Vervaet C, Vanhoorne V. Studying the API Distribution of Controlled Release Formulations Produced via Continuous Twin-Screw Wet Granulation: Influence of Matrix Former, Filler and Process Parameters. Pharmaceutics. 2024 Feb 28;16(3):341. doi:10.3390/pharmaceutics16030341 PubMed PMID: 38543235; PubMed Central PMCID: PMC10974511.
    18. Shanmugam S. Granulation techniques and technologies: recent progresses. BioImpacts BI. 2015;5(1):55–63. doi:10.15171/bi.2015.04 PubMed PMID: 25901297; PubMed Central PMCID: PMC4401168.
    19. Vadaga AK, Gudla SS, Nareboina GSK, Gubbala H, Golla B. Comprehensive review on modern techniques of granulation in pharmaceutical solid dosage forms. Intell Pharm. 2024 Oct 1;2(5):609–29. doi:10.1016/j.ipha.2024.05.006
    20. Li M heng, Zeng Y, Lin W, Liu S rui, Li Y liang, Shi Q zhi, et al. Preparation and evaluation of immediate and modified release tablets contained diphenidol hydrochloride. Sci Rep. 2025 Aug 29;15:31834. doi:10.1038/s41598-025-17335-0 PubMed PMID: 40883507; PubMed Central PMCID: PMC12397357.
    21. Bose A, Wong TW, Singh N. Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics. Saudi Pharm J SPJ. 2013 Apr;21(2):201–13. doi:10.1016/j.jsps.2012.03.006 PubMed PMID: 23960836; PubMed Central PMCID: PMC3744972.
    22. Walsh E, Maclean N, Turner A, Alsuleman M, Prasad E, Halbert G, et al. Manufacture of tablets with structurally-controlled drug release using rapid tooling injection moulding. Int J Pharm. 2022 Aug 25;624:121956. doi:10.1016/j.ijpharm.2022.121956 PubMed PMID: 35760259.
    23. Ervasti T, Simonaho SP, Ketolainen J, Forsberg P, Fransson M, Wikström H, et al. Continuous manufacturing of extended release tablets via powder mixing and direct compression. Int J Pharm. 2015 Nov 10;495(1):290–301. doi:10.1016/j.ijpharm.2015.08.077 PubMed PMID: 26320548.
    24. Costa C, Casimiro T, Corvo ML, Aguiar-Ricardo A. Solid Dosage Forms of Biopharmaceuticals in Drug Delivery Systems Using Sustainable Strategies. Molecules. 2021 Dec 17;26(24):7653. doi:10.3390/molecules26247653 PubMed PMID: 34946733; PubMed Central PMCID: PMC8708471.
    25. Öztürk AA, Namlı İ, Güleç K, Kıyan HT. Diclofenac sodium loaded PLGA nanoparticles for inflammatory diseases with high anti-inflammatory properties at low dose: Formulation, characterization and in vivo HET-CAM analysis. Microvasc Res. 2020 Jul 1;130:103991. doi:10.1016/j.mvr.2020.103991
    26. Samie M, Bashir S, Abbas J, Khan S, Aman N, Jan H, et al. Design, Formulation and In Vitro Evaluation of Sustained-release Tablet Formulations of Levosulpiride. Turk J Pharm Sci. 2018 Nov 20. doi:10.4274/tjps.29200
    27. Khan R, Ashraf MS, Afzal M, Kazmi I, Jahangir MA, Singh R, et al. Formulation and evaluation of sustained release matrix tablet of rabeprazole using wet granulation technique. J Pharm Bioallied Sci. 2014;6(3):180–4. doi:10.4103/0975-7406.130961 PubMed PMID: 25035637; PubMed Central PMCID: PMC4097931.

Reference

    1. Fell JT, Newton JM. Determination of Tablet Strength by the Diametral-Compression Test. J Pharm Sci. 1970 May 1;59(5):688–91. doi:10.1002/jps.2600590523
    2. Colombo P, Bettini R, Santi P, De Ascentiis A, Peppas NA. Analysis of the swelling and release mechanisms from drug delivery systems with emphasis on drug solubility and water transport. J Controlled Release. 1996 May 1;Proceedings of the Seventh International Symposium on Recent Advances in Drug Delivery Systems39(2):231–7. doi:10.1016/0168-3659(95)00158-1
    3. Alqahtani MS, Kazi M, Alsenaidy MA, Ahmad MZ. Advances in Oral Drug Delivery. Front Pharmacol. 2021 Feb 19;12:618411. doi:10.3389/fphar.2021.618411 PubMed PMID: 33679401; PubMed Central PMCID: PMC7933596.
    4. Lin L, Wong H. Predicting Oral Drug Absorption: Mini Review on Physiologically-Based Pharmacokinetic Models. Pharmaceutics. 2017 Sep 26;9(4):41. doi:10.3390/pharmaceutics9040041 PubMed PMID: 28954416; PubMed Central PMCID: PMC5750647.
    5. Fuhrman LC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 8th Edition. Am J Pharm Educ. 2006 Jun 15;70(3):71. PubMed PMID: null; PubMed Central PMCID: PMC1636965.
    6. Aulton’s Pharmaceutics [Internet]. [cited 2026 May 6]. Available from: https://elsevier-elibrary.com/contents/fullcontent/58070/epubcontent_v2/OEBPS/xhtml/CHP031.html
    7. Sugandini G, Reddy MS. An Overview on Classification, Mechanism of Extended Release Drug Delivery of Oral Formulations. J Drug Discov Ther. 2023 Jun 28;11(3):06–17. doi:10.32553/jddt.v11i3.472
    8. Khobragade DS, Agrawal SS, Potbhare MS. Pharmacokinetic Considerations for Controlledrelease Dosage Forms. In: Novel Drug Delivery Systems (Part 1) [Internet]. Bentham Science Publishers; 2024 [cited 2026 May 6]. p. 39–86. Available from: https://www.benthamdirect.com/content/books/9789815274165.chapter-2
    9. 066c837e42600d_Ch-1_DK Tripathi - Drug Delivery Systems.pdf [Internet]. [cited 2026 May 6]. Available from: https://bspublications.net/downloads/066c837e42600d_Ch-1_DK%20Tripathi%20-%20Drug%20Delivery%20Systems.pdf
    10. Adepu S, Ramakrishna S. Controlled Drug Delivery Systems: Current Status and Future Directions. Molecules. 2021 Sep 29;26(19):5905. doi:10.3390/molecules26195905 PubMed PMID: 34641447; PubMed Central PMCID: PMC8512302.
    11. Choudhary A. Sustained Release and Prolonged Release Tablets and their Difference [Internet]. [cited 2026 May 6]. Available from: https://www.pharmaguideline.com/2018/01/difference-between-sustained-prolonged-release-tablets.html
    12. Efentakis M, Peponaki C. Formulation Study and Evaluation of Matrix and Three-layer Tablet Sustained Drug Delivery Systems Based on Carbopols with Isosorbite Mononitrate. AAPS PharmSciTech. 2008 Aug 7;9(3):917–23. doi:10.1208/s12249-008-9084-2 PubMed PMID: 18686040; PubMed Central PMCID: PMC2977044.
    13. Merchant HA, Babar ZUD, Hussain IM. A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies. J Pharm Policy Pract. 2022 Dec 22;15:104. doi:10.1186/s40545-022-00501-4 PubMed PMID: 36550588; PubMed Central PMCID: PMC9773520.
    14. Sohail Arshad M, Zafar S, Yousef B, Alyassin Y, Ali R, AlAsiri A, et al. A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing. Adv Drug Deliv Rev. 2021 Nov 1;178:113840. doi:10.1016/j.addr.2021.113840
    15. Suzuki Y, Sugiyama H, Kano M, Shimono R, Shimada G, Furukawa R, et al. Control strategy and methods for continuous direct compression processes. Asian J Pharm Sci. 2021 Mar;16(2):253–62. doi:10.1016/j.ajps.2020.11.005 PubMed PMID: 33995618; PubMed Central PMCID: PMC8105518.
    16. Chen H, Aburub A, Sun CC. Direct Compression Tablet Containing 99% Active Ingredient—A Tale of Spherical Crystallization. J Pharm Sci. 2019 Apr 1;108(4):1396–400. doi:10.1016/j.xphs.2018.11.015
    17. Denduyver P, Vervaet C, Vanhoorne V. Studying the API Distribution of Controlled Release Formulations Produced via Continuous Twin-Screw Wet Granulation: Influence of Matrix Former, Filler and Process Parameters. Pharmaceutics. 2024 Feb 28;16(3):341. doi:10.3390/pharmaceutics16030341 PubMed PMID: 38543235; PubMed Central PMCID: PMC10974511.
    18. Shanmugam S. Granulation techniques and technologies: recent progresses. BioImpacts BI. 2015;5(1):55–63. doi:10.15171/bi.2015.04 PubMed PMID: 25901297; PubMed Central PMCID: PMC4401168.
    19. Vadaga AK, Gudla SS, Nareboina GSK, Gubbala H, Golla B. Comprehensive review on modern techniques of granulation in pharmaceutical solid dosage forms. Intell Pharm. 2024 Oct 1;2(5):609–29. doi:10.1016/j.ipha.2024.05.006
    20. Li M heng, Zeng Y, Lin W, Liu S rui, Li Y liang, Shi Q zhi, et al. Preparation and evaluation of immediate and modified release tablets contained diphenidol hydrochloride. Sci Rep. 2025 Aug 29;15:31834. doi:10.1038/s41598-025-17335-0 PubMed PMID: 40883507; PubMed Central PMCID: PMC12397357.
    21. Bose A, Wong TW, Singh N. Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics. Saudi Pharm J SPJ. 2013 Apr;21(2):201–13. doi:10.1016/j.jsps.2012.03.006 PubMed PMID: 23960836; PubMed Central PMCID: PMC3744972.
    22. Walsh E, Maclean N, Turner A, Alsuleman M, Prasad E, Halbert G, et al. Manufacture of tablets with structurally-controlled drug release using rapid tooling injection moulding. Int J Pharm. 2022 Aug 25;624:121956. doi:10.1016/j.ijpharm.2022.121956 PubMed PMID: 35760259.
    23. Ervasti T, Simonaho SP, Ketolainen J, Forsberg P, Fransson M, Wikström H, et al. Continuous manufacturing of extended release tablets via powder mixing and direct compression. Int J Pharm. 2015 Nov 10;495(1):290–301. doi:10.1016/j.ijpharm.2015.08.077 PubMed PMID: 26320548.
    24. Costa C, Casimiro T, Corvo ML, Aguiar-Ricardo A. Solid Dosage Forms of Biopharmaceuticals in Drug Delivery Systems Using Sustainable Strategies. Molecules. 2021 Dec 17;26(24):7653. doi:10.3390/molecules26247653 PubMed PMID: 34946733; PubMed Central PMCID: PMC8708471.
    25. Öztürk AA, Naml? ?, Güleç K, K?yan HT. Diclofenac sodium loaded PLGA nanoparticles for inflammatory diseases with high anti-inflammatory properties at low dose: Formulation, characterization and in vivo HET-CAM analysis. Microvasc Res. 2020 Jul 1;130:103991. doi:10.1016/j.mvr.2020.103991
    26. Samie M, Bashir S, Abbas J, Khan S, Aman N, Jan H, et al. Design, Formulation and In Vitro Evaluation of Sustained-release Tablet Formulations of Levosulpiride. Turk J Pharm Sci. 2018 Nov 20. doi:10.4274/tjps.29200
    27. Khan R, Ashraf MS, Afzal M, Kazmi I, Jahangir MA, Singh R, et al. Formulation and evaluation of sustained release matrix tablet of rabeprazole using wet granulation technique. J Pharm Bioallied Sci. 2014;6(3):180–4. doi:10.4103/0975-7406.130961 PubMed PMID: 25035637; PubMed Central PMCID: PMC4097931.

Photo
Kunal Tanwar
Corresponding author

M. Pharm Research scholar, Lords University, Alwar , Rajasthan ,301028

Photo
Dr. Mukesh Gupta
Co-author

Professor and Dean, Lords University, Alwar, Rajasthan, 301028

Photo
Chander Singh
Co-author

Pavitra Institute of Pharmacy, Gurugram, Haryana, 122102

Kunal Tanwar, Mukesh Gupta, Chander Singh , Development, Optimization and Comparative Evaluation of Diclofenac Sodium Sustained Release Matrix Tablets Using Polymers, , Int. J. of Pharm. Sci., 2026, Vol 4, Issue 5, 6887-6906, https://doi.org/10.5281/zenodo.20395695

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