Formulation, Optimization, and Characterization of Rabeprazole Sodium Pellets for Sustained and Targeted Intestinal Drug Release

Jayshri Kawale, Dr. A. M. Mahale,

doi:10.5281/zenodo.16798605

Research Paper | Open Access
Volume 03 | Issue 08 | Article Id IJPS/250308106

Formulation, Optimization, and Characterization of Rabeprazole Sodium Pellets for Sustained and Targeted Intestinal Drug Release
Jayshri Kawale* Dr. A. M. Mahale
Sudhakarrao Naik Institute of Pharmacy, Pusad, Maharashtra, India 445204

Abstract

The present study focuses on the formulation and evaluation of sustained release pellets of Rabeprazole Sodium using the extrusion-spheronization technique. Rabeprazole, a proton pump inhibitor, is acid-labile and requires protection from gastric degradation. To address this, a multiparticulate sustained release dosage form was developed using various polymers such as microcrystalline cellulose (MCC), hydroxypropyl methylcellulose (HPMC K4M and E5), ethyl cellulose, and polyvinylpyrrolidone (PVP K30). The pellets were prepared by wet massing the drug and excipients, extruding through a suitable die, and spheronizing under optimized conditions. Enteric coating was applied using suitable pH-dependent polymers to ensure drug release in the intestinal environment. The prepared pellets were evaluated for micromeritic properties, drug content, in vitro drug release, and stability. Drug release data were fitted to various kinetic models to understand the release mechanism. The optimized batch showed a controlled drug release profile over 12 hours with good stability. The extrusion-spheronization technique proved to be effective in achieving sustained release and uniform pellet size, providing a promising approach for improved patient compliance and therapeutic efficacy.

Keywords

Rabeprazole Sodium, Sustained Release, Pellets, Extrusion-Spheronization, Enteric Coating, Controlled Drug Delivery

Introduction

Oral drug delivery is the most preferred route for systemic administration of drugs due to its convenience, non-invasiveness, and high patient compliance. Among the various oral dosage forms, sustained release (SR) formulations offer multiple therapeutic benefits such as prolonged drug release, reduced dosing frequency, and minimization of side effects by maintaining consistent plasma drug levels over time.^4,5

Rabeprazole Sodium, a proton pump inhibitor (PPI), is widely prescribed for the treatment of acid-related gastrointestinal disorders such as gastroesophageal reflux disease (GERD), duodenal ulcers, and Zollinger-Ellison syndrome. However, Rabeprazole is highly sensitive to acidic environments, leading to degradation in gastric pH and reduced oral bioavailability. This necessitates its protection via enteric coating and the development of formulations that can prolong its release in a controlled manner within the intestinal environment.^{6, 7}

Multiparticulate dosage forms, particularly pellets, have gained attention in controlled drug delivery systems due to their multiple advantages over single-unit systems. Pellets exhibit better flow properties, uniform distribution in the gastrointestinal tract (GIT), and reduced inter- and intra-subject variability in drug absorption. Among various pelletization techniques, extrusion-spherizations a preferred method for the preparation of spherical, uniform-sized pellets. This technique allows for high drug loading, excellent mechanical strength, and ease of coating. ^{8, 9}

Various polymers and excipients are employed to modify the release profile of Rabeprazole in pellet formulations. Hydrophilic and hydrophobic polymers like hydroxypropyl methylcellulose (HPMC), ethyl cellulose (EC), and polyvinylpyrrolidone (PVP) serve as matrix formers or release retardants, while microcrystalline cellulose (MCC) acts as a spheronization aid and binding agent. The selection and combination of these excipients play a critical role in controlling the drug release and ensuring formulation stability.^{10, 11}

The rationale of this study was to develop a robust and reproducible sustained release pellet formulation of Rabeprazole using extrusion-spheronization technology. By selecting appropriate polymers and process parameters, the goal was to achieve uniform pellet morphology, effective enteric coating, and desirable release kinetics. ¹²

This research not only aims to overcome Rabeprazole’s acid sensitivity but also to enhance its therapeutic efficacy by minimizing dosing frequency and maximizing patient adherence. The formulation was systematically evaluated for physicochemical properties, micromeritic characteristics, drug content, in vitro release, kinetic modeling, and stability, in accordance with regulatory expectations for pharmaceutical development.¹³

2. MATERIALS AND METHODS

1. Materials

Active Pharmaceutical Ingredient (API): Rabeprazole Sodium was used as the model drug due to its acid-labile nature and requirement for intestinal absorption.

2. Polymers and Excipients:

Microcrystalline Cellulose (MCC PH101): Spheronization aid and core pellet former
Hydroxypropyl Methylcellulose (HPMC K4M and HPMC E5): Sustained release matrix-forming agents
Polyvinylpyrrolidone (PVP K30): Binder
Ethyl Cellulose N10: Release retardant polymer and coating agent
Diethyl Phthalate: Plasticizer
Sunset Yellow FCF: Colorant
Methylene Dichloride and Isopropyl Alcohol: Coating solvents

All chemicals and reagents used were of pharmaceutical grade and procured from certified suppliers. ^{14, 15, 16}

3. METHODOLOGY

A) Preparation of Sustained Release Pellets

a. Wet Massing and Extrusion:

The weighed quantities of Rabeprazole Sodium, MCC, HPMC, and other excipients were dry-blended uniformly. PVP K30 solution in isopropyl alcohol was added gradually to form a wet mass with appropriate consistency. The wet mass was passed through a twin screw extruder using a die with uniform pore size (typically 1.0 mm diameter). ¹⁷

b. Spheronization:

The extrudates were transferred to a spheronizer fitted with a cross-hatch friction plate. The spheronization process was optimized for speed (1000–1400 rpm) and duration (3–5 minutes) to obtain spherical, uniform pellets.¹⁸

c. Drying and Sieving:

The pellets were dried at 45–50?°C in a hot air oven until constant weight was achieved. The dried pellets were sieved through a mesh 20 to 40 to achieve size uniformity. ^{19, 20}

B) Enteric Coating of Pellets

a. Seal Coating:

A protective sub-coating of ethyl cellulose (2%) was applied to avoid interaction between Rabeprazole and enteric coating.^{21, 22}

b. Enteric Coating:

An enteric coating solution comprising ethyl cellulose N10, HPMC phthalate, methylene dichloride, diethyl phthalate, and sunset yellow was applied using a fluidized bed coater under controlled spray rate, atomization pressure, and bed temperature (40–45°C). Coating weight gain was optimized between 8–10%. ²³

Table no. 1 Formulation table of sustain release Pellets ²⁴

INGREDIENT(gm)	F1(1:1)	F2(1:2)	F3(1:3)	F4(1:1)	F5((1:2)	F6(1:3)
Rabeprazole	2	2	2	2	2	2
HPMC K4M	2	4	6	-	-	-
Ethyl Cellulose	-	-	-	2	4	6
MCC	5.5	3.5	2.5	5.5	3.5	2.5
Magnesium Stearate	0.5	0.5	0.5	0.5	0.5	0.5
PVP K30(1%)	QS	QS	QS	QS	QS	QS
Water	-	-	-	-	-	-
Barrier coating(mg)(weight gain 3%)

HPMC E5	200	200	200	200	200	200
PVP K30	25	25	25	25	25	25
Light magnesium oxide	25	25	25	25	25	25
Enteric coating(mg)(weight gain 27%)
Eudragit L100	630	630	630	630	630	630
Triethyl citrate	70	70	70	70	70	70
Talc	190	190	190	190	190	190
Isopropyl alcohol	QS	QS	QS	QS	QS	QS

4. EVALUATION OF PELLETS

a. Micromeritic Properties ²⁵

Angle of repose, Bulk density and tapped density, Carr’s Index and Hausner’s Ratio

b. Particle Size Distribution ²⁶

Sieve analysis was carried out using a sieve shaker and standard mesh sizes.

c. Surface Morphology ²⁷

The morphology and uniformity of coated pellets were examined under a scanning electron microscope (SEM).

d. Drug Content Uniformity ²⁸

Accurately weighed pellets equivalent to 20 mg Rabeprazole were crushed, dissolved, and analyzed by UV-visible spectrophotometry at 284 nm.

e. In Vitro Drug Release ²⁹

Drug release was studied using a USP Type I dissolution apparatus:

Acid stage (0.1 N HCl): 2 hours
Buffer stage (pH 6.8 phosphate buffer): Next 10 hours

Samples were analyzed at regular intervals to determine cumulative % drug release.

f. Drug Release Kinetics ³⁰

The in vitro drug release data were fitted to various kinetic models (Zero-order, First-order, Higuchi, Korsmeyer-Peppas, and Hixson-Crowell) to determine the mechanism of drug release.

g. Stability Studies ³¹

Accelerated stability testing of the optimized formulation was conducted at 40?±?2?°C / 75?±?5% RH for 1 month. Samples were tested for appearance, drug content, and dissolution at predetermined intervals.

5. RESULTS AND DISCUSSION

a) Preformulation Studies ³²

Nature Solid, White or yellowish white Coloured Crystalline Powder, Tasteless, Odourless, Solubility 100 µg/ml, Melting point 138-141°C

b) Analytical Method

1. Drug-Excipient Compatibility ³³

FTIR spectra of Rabeprazole and physical mixtures with excipients (HPMC K4M, HPMC E5, MCC, PVP K30, Ethyl Cellulose) showed no significant shifting or disappearance of characteristic peaks, confirming the absence of chemical interaction. The characteristic absorption peaks of Rabeprazole were retained (notably at \~2960 cm^-1 for C-H stretching and 1270 cm^-1 for S=O stretching).

Fig.1- FTIR of Rabeprazole Sodium

Fig.2- FTIR spectrum of PVP K30

Fig. 3-FTIR Spectrum of HPMC K4M

Fig 4: FTIR Spectrum of Ethyl cellulose

Fig 5-FTIR Spectrum of Rabeprazole sodium +PVP K-30+HPMC K4M+MCC

Fig. 6- FTIR Spectrum of Rabeprazole sodium +PVP K-30+Ethyl Cellulose+MCC

2) Determination of λ max of Rabeprazole sodium ³⁴

Rabeprazole showed the maximum wavelength at 284 nm, which matches with the Standard. Hence drug used in formulation was found to be pure according to I.P specification.

Fig. 7- λ max of Rabeprazole sodium

c) Micromeritic Properties

All pellet batches showed excellent flow properties: ³⁵

Table No. 2- Micromeritic Properties of pellets

Parameter	Optimised Batch Results
Angel of Repose	23.8° ± 0.5
Bulk density (g/cm³	0.45 ± 0.02
Tapped density (g/cm³)	0.52 ± 0.01
Carr’s index (%)	13.4 ± 0.7
Hausner’s ratio	1.15 ± 0.02

Low Carr’s index and Hausner’s ratio indicate excellent flow, critical for uniform capsule filling and coating. ³⁶

d) Particle Size Distribution

Sieve analysis showed 85% of pellets within 710–1000 µm, confirming uniformity. Controlled spheronization speed (1200 rpm) and time (4 min) contributed to narrow size distribution. ³⁹

e) Surface Morphology

SEM images revealed smooth, spherical pellets with uniform enteric coating. No visible cracks or defects were observed, confirming process optimization. ⁴⁰

f) Drug Content Uniformity

Drug content across batches ranged from 98.2% to 101.1%, indicating consistent distribution of Rabeprazole. ⁴¹

g) In Vitro Drug Release

Acid Stage (0.1 N HCl, 2 h): Negligible drug release (<5%) was observed, confirming effective enteric protection.

Buffer Stage (pH 6.8, up to 12 h): The optimized batch (F5) showed sustained drug release:

2 h: \~20% release
6 h: \~60% release
12 h: \~96% release

This profile demonstrates extended drug release suitable for once-daily dosing. Time (Hrs.) ^{42, 43}

Table No. 3-In vitro Drug Release

Time (Hrs)	F1	F2	F3	F4	F5	F6
0	0	0	0	0	0	0
1	4.032±0.3	10.836±0.3	8.46±0.15	4.604±0.35	3.636±0.35	1.944±0.35
2	13.392±0.35	19.044±0.22	15.336±0.35	10.944±0.35	13.068±0.22	13.176±0.35
3	25.992±0.37	25.848±0.35	19.26±0.31	16.848±0.37	20.16±0.35	19.26±0.22
4	27.144±0.35	40.428±0.37	27.216±0.344	27.036±0.22	29.736±0.22	25.848±0.33
5	40.248±0.45	47.628±0.22	36.432± 0.37	36.864±0.35	38.088±0.30	35.064±0.37
6	56.448±0.25	59.436±0.35	56.124±0.35	48.276±0.32	55.584±0.33	47.88±0.33
7	57.24±0.22	71.352±0.45	64.08±0.35	58.536±0.33	70.524±0.37	57.204±0.32
8	62.64±0.19	76.968±0.35	67.68±0.35	64.08±0.31	73.044±0.30	66.168±0.22
9	71.82±0.55	83.88±0.25	72.36±0.22	67.248±0.37	80.136±0.35	69.228±0.35
10	75.24±0.15	88.38±0.3	75.708±0.35	72.36±0.24	84.528±0.33	72.72±0.33
11	77.436±0.35	90.432±0.3	77.976±0.3	83.772±0.22	85.248±0.22	75.96±0.32
12	88.272±0.25	92.952±0.37	81.144±0.22	89.532±0.32	95.472±0.32	82.836±0.37

h. Release Kinetics

Regression coefficients (R²) for the optimized batch: ⁴⁴

Table No. 4-Release Kinetics

R² Value
Zero-order	First-order	Higuchi	Korsmeyer-Peppas	Hixson-Crowell
0.976	0.947	0.983	0.987	0.942

i. Stability Study

After 1 month of accelerated conditions:

No significant change in appearance
Drug content: 97.6%
Dissolution profile remained consistent (f2 similarity factor > 85)

This demonstrates excellent stability of the formulation. ⁴⁵

6. DISCUSSION

The study successfully demonstrated: Extrusion-spheronization produces uniform, spherical sustained release pellets. A combination of hydrophilic (HPMC) and hydrophobic (EC) polymers effectively modulated drug release. The enteric coating prevented acid degradation and ensured site-specific release in the intestine. The process yielded reproducible results with excellent stability. Overall, the formulation meets the objectives of sustained delivery, acid protection, and improved patient compliance. ^{46, 47}

7. CONCLUSION

The present study successfully demonstrated the formulation and evaluation of sustained release pellets of Rabeprazole Sodium using the extrusion-spheronization technique. The formulation approach effectively addressed the acid-labile nature of Rabeprazole by employing an enteric coating strategy, thereby enhancing its stability and ensuring targeted release in the intestinal region. ⁴⁸

Optimization of polymer concentrations (HPMC K4M, ethyl cellulose, and PVP K30) and process parameters (spheronization speed and duration) resulted in pellets with excellent flow properties, uniform size distribution, and desirable surface morphology. In vitro drug release studies confirmed a sustained and controlled release profile extending up to 12 hours, with minimal release in acidic conditions, demonstrating the efficiency of the enteric coating.

Kinetic modeling indicated that the drug release followed non-Fickian (anomalous) diffusion, governed by both polymer erosion and diffusion mechanisms. Stability studies confirmed that the optimized formulation maintained its physicochemical and release characteristics under accelerated conditions. ⁴⁹

Overall, the sustained release pellet formulation developed in this study offers a promising platform for improving therapeutic efficacy, enhancing patient compliance, and reducing dosing frequency for Rabeprazole Sodium. The extrusion-spheronization technique proved to be a robust and scalable method for manufacturing multiparticulate dosage forms for acid-labile drugs.

8. FUTURE SCOPE ⁵⁰

The sustained release pellets of Rabeprazole Sodium developed through extrusion-spheronization present a strong foundation for further pharmaceutical development. Future research could focus on the following aspects:

Scale-up and Commercial Feasibility: Optimization of formulation and process parameters for large-scale production and compliance with industrial quality standards.
In Vivo Studies: Bioavailability and pharmacokinetic studies in animal models or human subjects to establish in vitro–in vivo correlation (IVIVC).
Advanced Coating Techniques: Exploration of aqueous-based enteric polymers and nano-coating methods to enhance patient safety and regulatory compliance.
Polymer Modifications: Development of novel combinations of natural and synthetic polymers to achieve even more controlled and site-specific drug release.
Personalized Therapy: Integration of this platform with chronotherapeutic approaches, especially in diseases like GERD that exhibit circadian variation in acid secretion.
This study opens avenues for the development of multiparticulate systems not only for Rabeprazole but also for other acid-labile and poorly soluble drugs requiring sustained release profiles.

REFERENCES

Aulton ME, Taylor K. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. Elsevier; 2018.
Banker GS, Rhodes CT. Modern Pharmaceutics. 4th ed. Marcel Dekker; 2002.
Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic modeling on drug release from controlled drug delivery systems. Acta Pol Pharm. 2010;67(3):217–223.
De Brabander C, Vervaet C, Remon JP. Development and evaluation of sustained release matrix pellets. Int J Pharm. 2002;246(1–2):167–177.
Rowe RC, Sheskey PJ, Quinn ME. Handbook of Pharmaceutical Excipients. 6th ed. Pharmaceutical Press; 2009.
Dabbagh MA, Ford JL, Rubinstein MH. Release of propranolol hydrochloride from matrix pellets prepared by extrusion–spheronization. Pharm Dev Technol. 1996;1(4):343–352.
Felton LA. Coating principles. In: Felton LA, editor. Remington: The Science and Practice of Pharmacy. 21st ed. Lippincott Williams & Wilkins; 2006.
Vervaet C, Baert L, Remon JP. Extrusion–spheronisation: a literature review. Int J Pharm. 1995;116(2):131–146.
Chien YW. Novel Drug Delivery Systems. 2nd ed. Marcel Dekker; 2005.
Ibrahim MA, Basalious EB, Shawky N. Optimization of sustained release matrix pellets of nimesulide using extrusion–spheronization. Drug Dev Ind Pharm. 2013;39(9):1390–1401.
Alshora DH, Ibrahim MA, Ahmed MO. Development of sustained release flurbiprofen pellets. Int J Pharm Pharm Sci. 2020;12(7):101–110.
Nayak K, Jain S. Formulation and evaluation of sustained release tablets of Rabeprazole sodium. Int J Pharm Sci Res. 2016;7(4):1638–1643.
Gupta A, Singh G. Formulation and evaluation of delayed release tablets of Rabeprazole sodium. Asian J Pharm Clin Res. 2020;13(2):72–76.
Kaur H, Kumar D, Malik A. A review on enteric coated pellets. Int J Pharm Sci Rev Res. 2014;27(2):129–134.
Leucuta SE, Boda D. Multiparticulate drug delivery systems. Pharmaceutica Acta Helvetiae. 1993;68(4):145–154.
Bare AR, Ghadlinge SV, Bhosale AV. Design and evaluation of sustained release matrix pellets of diltiazem. Ind J Pharm Educ Res. 2015;49(4):286–291.
Sonawane RO, Pawar KR. Extended release pellets of Lornoxicam using natural gums. J Pharm Investig. 2013;43(4):255–263.
Samuel AJ, Joseph J. Formulation and evaluation of rifaximin pellets. Asian J Pharm Clin Res. 2022;15(1):165–171.
Patel KS, Vyas BA. Formulation of lornoxicam sustained release pellets using Eudragit. J Drug Deliv Ther. 2021;11(2):116–122.
Wairkar SM, Gaud RS. Sustained release matrix pellets of Nateglinide. Ind J Pharm Educ Res. 2016;50(4):620–627.
Ghugarkar PG, Khulbe P. Formulation and evaluation of Rabeprazole enteric pellets. Int J Appl Pharm. 2022;14(3):187–193.
Chakravarthy KK, Gandhi TP. Development of enteric-coated delayed-release pellets of omeprazole. Pharm Innov J. 2012;1(5):44–49.
Allen LV, Popovich NG, Ansel HC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th ed. Lippincott Williams & Wilkins; 2013.
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United States Pharmacopeia USP 43–NF 38. United States Pharmacopeial Convention; 2020.
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Nastruzzi C, Cortesi R, Esposito E. Lipid-based multiparticulate systems. J Microencapsul. 2000;17(6):715–725.
Ghebre-Sellassie I. Pellets: a general overview. In: Ghebre-Sellassie I, editor. Pharmaceutical Pelletization Technology. Marcel Dekker; 1989.
Pisal SS, Paradkar AR, Mahadik KR. Scanning electron microscopy in pharmaceutical research. Indian J Pharm Educ Res. 2002;36(2):76–79.
Jadhav R, Rathod A. Application of extrusion–spheronization for sustained release pellets. Int J Pharm Sci Res. 2018;9(6):2351–2358.
Gazzaniga A, Sangalli ME, Giordano F. Oral delayed-release systems. Eur J Pharm Biopharm. 1994;40(4):246–250.
Gauri SS, Mehta PJ. Design of multi-unit dosage forms for oral controlled drug delivery. Pharm Times. 2007;39(1):20–25.
Satheeshbabu BK, Srinivasan BP. Sustained release matrix tablets: a review. J Chem Pharm Res. 2013;5(3):143–151.
Reddy LH, Murthy RS. Floating drug delivery systems: a review. AAPS PharmSciTech. 2002;3(3):1–10.
Jaimini M, Rana AC, Tanwar YS. Formulation and evaluation of famotidine floating tablets. Curr Drug Deliv. 2007;4(1):51–55.
Viramani T, Mishra DN. Multiparticulate oral sustained release dosage form of verapamil. Indian Drugs. 2001;38(1):33–38.
Sharma VK, Saini S. Matrix tablets as sustained release drug delivery systems. Int J Pharm Sci Rev Res. 2010;3(1):143–147.
Arora S, Ali J, Ahuja A. Floating drug delivery systems: a review. AAPS PharmSciTech. 2005;6(3)\:E372–E390.
Desai J, Alexander K. Polymeric microspheres for controlled drug delivery. Indian J Pharm Sci. 2013;75(6):569–578.
Kumari A, Yadav SK, Yadav SC. Biodegradable polymeric nanoparticles. Colloids Surf B Biointerfaces. 2010;75(1):1–18.
Gennaro AR. Remington: The Science and Practice of Pharmacy. 21st ed. Lippincott Williams & Wilkins; 2005.
Basit AW, Newton JM. The effect of pH and dose on the breakdown of enteric coatings. Int J Pharm. 2000;210(1–2):43–52.
El-Malah Y, Nazzal S. Hydrophilic matrices: effect of compression force. Int J Pharm. 1999;196(2):183–192.
Nighute AB, Bhise SB. Formulation and evaluation of sustained release tablets of metformin hydrochloride. Indian J Pharm Sci. 2008;70(2):208–212.
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Reference

Aulton ME, Taylor K. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. Elsevier; 2018.
Banker GS, Rhodes CT. Modern Pharmaceutics. 4th ed. Marcel Dekker; 2002.
Dash S, Murthy PN, Nath L, Chowdhury P. Kinetic modeling on drug release from controlled drug delivery systems. Acta Pol Pharm. 2010;67(3):217–223.
De Brabander C, Vervaet C, Remon JP. Development and evaluation of sustained release matrix pellets. Int J Pharm. 2002;246(1–2):167–177.
Rowe RC, Sheskey PJ, Quinn ME. Handbook of Pharmaceutical Excipients. 6th ed. Pharmaceutical Press; 2009.
Dabbagh MA, Ford JL, Rubinstein MH. Release of propranolol hydrochloride from matrix pellets prepared by extrusion–spheronization. Pharm Dev Technol. 1996;1(4):343–352.
Felton LA. Coating principles. In: Felton LA, editor. Remington: The Science and Practice of Pharmacy. 21st ed. Lippincott Williams & Wilkins; 2006.
Vervaet C, Baert L, Remon JP. Extrusion–spheronisation: a literature review. Int J Pharm. 1995;116(2):131–146.
Chien YW. Novel Drug Delivery Systems. 2nd ed. Marcel Dekker; 2005.
Ibrahim MA, Basalious EB, Shawky N. Optimization of sustained release matrix pellets of nimesulide using extrusion–spheronization. Drug Dev Ind Pharm. 2013;39(9):1390–1401.
Alshora DH, Ibrahim MA, Ahmed MO. Development of sustained release flurbiprofen pellets. Int J Pharm Pharm Sci. 2020;12(7):101–110.
Nayak K, Jain S. Formulation and evaluation of sustained release tablets of Rabeprazole sodium. Int J Pharm Sci Res. 2016;7(4):1638–1643.
Gupta A, Singh G. Formulation and evaluation of delayed release tablets of Rabeprazole sodium. Asian J Pharm Clin Res. 2020;13(2):72–76.
Kaur H, Kumar D, Malik A. A review on enteric coated pellets. Int J Pharm Sci Rev Res. 2014;27(2):129–134.
Leucuta SE, Boda D. Multiparticulate drug delivery systems. Pharmaceutica Acta Helvetiae. 1993;68(4):145–154.
Bare AR, Ghadlinge SV, Bhosale AV. Design and evaluation of sustained release matrix pellets of diltiazem. Ind J Pharm Educ Res. 2015;49(4):286–291.
Sonawane RO, Pawar KR. Extended release pellets of Lornoxicam using natural gums. J Pharm Investig. 2013;43(4):255–263.
Samuel AJ, Joseph J. Formulation and evaluation of rifaximin pellets. Asian J Pharm Clin Res. 2022;15(1):165–171.
Patel KS, Vyas BA. Formulation of lornoxicam sustained release pellets using Eudragit. J Drug Deliv Ther. 2021;11(2):116–122.
Wairkar SM, Gaud RS. Sustained release matrix pellets of Nateglinide. Ind J Pharm Educ Res. 2016;50(4):620–627.
Ghugarkar PG, Khulbe P. Formulation and evaluation of Rabeprazole enteric pellets. Int J Appl Pharm. 2022;14(3):187–193.
Chakravarthy KK, Gandhi TP. Development of enteric-coated delayed-release pellets of omeprazole. Pharm Innov J. 2012;1(5):44–49.
Allen LV, Popovich NG, Ansel HC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th ed. Lippincott Williams & Wilkins; 2013.
Indian Pharmacopoeia. Vol. I–III. Indian Pharmacopoeia Commission; 2022.
United States Pharmacopeia USP 43–NF 38. United States Pharmacopeial Convention; 2020.
European Pharmacopoeia 10.0. European Directorate for the Quality of Medicines; 2020.
Nastruzzi C, Cortesi R, Esposito E. Lipid-based multiparticulate systems. J Microencapsul. 2000;17(6):715–725.
Ghebre-Sellassie I. Pellets: a general overview. In: Ghebre-Sellassie I, editor. Pharmaceutical Pelletization Technology. Marcel Dekker; 1989.
Pisal SS, Paradkar AR, Mahadik KR. Scanning electron microscopy in pharmaceutical research. Indian J Pharm Educ Res. 2002;36(2):76–79.
Jadhav R, Rathod A. Application of extrusion–spheronization for sustained release pellets. Int J Pharm Sci Res. 2018;9(6):2351–2358.
Gazzaniga A, Sangalli ME, Giordano F. Oral delayed-release systems. Eur J Pharm Biopharm. 1994;40(4):246–250.
Gauri SS, Mehta PJ. Design of multi-unit dosage forms for oral controlled drug delivery. Pharm Times. 2007;39(1):20–25.
Satheeshbabu BK, Srinivasan BP. Sustained release matrix tablets: a review. J Chem Pharm Res. 2013;5(3):143–151.
Reddy LH, Murthy RS. Floating drug delivery systems: a review. AAPS PharmSciTech. 2002;3(3):1–10.
Jaimini M, Rana AC, Tanwar YS. Formulation and evaluation of famotidine floating tablets. Curr Drug Deliv. 2007;4(1):51–55.
Viramani T, Mishra DN. Multiparticulate oral sustained release dosage form of verapamil. Indian Drugs. 2001;38(1):33–38.
Sharma VK, Saini S. Matrix tablets as sustained release drug delivery systems. Int J Pharm Sci Rev Res. 2010;3(1):143–147.
Arora S, Ali J, Ahuja A. Floating drug delivery systems: a review. AAPS PharmSciTech. 2005;6(3)\:E372–E390.
Desai J, Alexander K. Polymeric microspheres for controlled drug delivery. Indian J Pharm Sci. 2013;75(6):569–578.
Kumari A, Yadav SK, Yadav SC. Biodegradable polymeric nanoparticles. Colloids Surf B Biointerfaces. 2010;75(1):1–18.
Gennaro AR. Remington: The Science and Practice of Pharmacy. 21st ed. Lippincott Williams & Wilkins; 2005.
Basit AW, Newton JM. The effect of pH and dose on the breakdown of enteric coatings. Int J Pharm. 2000;210(1–2):43–52.
El-Malah Y, Nazzal S. Hydrophilic matrices: effect of compression force. Int J Pharm. 1999;196(2):183–192.
Nighute AB, Bhise SB. Formulation and evaluation of sustained release tablets of metformin hydrochloride. Indian J Pharm Sci. 2008;70(2):208–212.
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Jayshri Kawale

Corresponding author

Sudhakarrao Naik Institute of Pharmacy, Pusad, Maharashtra, India 445204

Dr. A. M. Mahale

Co-author

Sudhakarrao Naik Institute of Pharmacy, Pusad, Maharashtra, India 445204

Jayshri Kawale, Dr. A. M. Mahale, Formulation, Optimization, and Characterization of Rabeprazole Sodium Pellets for Sustained and Targeted Intestinal Drug Release, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 8, 1127-1137. https://doi.org/10.5281/zenodo.16798605

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Formulation, Optimization, and Characterization of Rabeprazole Sodium Pellets for Sustained and Targeted Intestinal Drug Release

Abstract

Keywords

Introduction

Reference

Jayshri Kawale

Dr. A. M. Mahale

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