A Comprehensive Study About Natural vs Synthetic Super Disintegrant used in the Development of Rizatriptan Benzoate Oral Flash Films

Oral route is the most preferred route for systemic drug delivery because of convenience, safety and high patient compliance, with tablets constituting nearly 60% of all solid dosage forms. However, geriatric, paediatric and dysphagic patients often face difficulty swallowing conventional tablets and capsules, which has driven the development of orodispersible and fast dissolving dosage forms. Oral fast dissolving films (OFDFs) are thin, flexible polymeric strips that rapidly wet, disintegrate and dissolve on the tongue or buccal mucosa, releasing drug for buccal, sublingual and/or gastrointestinal absorption without the need for water.

FDFs are typically prepared with hydrophilic film?forming polymers such as hydroxypropyl methylcellulose (HPMC), along with plasticizers, sweeteners, saliva stimulants, flavors and superdisintegrants. Advantages include improved patient compliance, ease of administration without water, rapid onset of action, potential reduction of first?pass metabolism, precise dosing, and suitability for motion sickness, migraine, acute pain and allergic attacks where rapid relief is needed. Limitations include restricted drug load (generally below 40 mg), dose?uniformity challenges, and the need for protective packaging due to film fragility and moisture sensitivity.

Rizatriptan benzoate is a selective 5?HT1B/1D receptor agonist indicated for acute treatment of migraine with or without aura. It exhibits rapid absorption but undergoes significant first?pass metabolism, resulting in oral bioavailability around 45%; peak plasma levels occur in 1–1.5 h and elimination half?life is 2–3 h. Because migraine attacks require rapid relief and patients may experience nausea, vomiting and intolerance to water, rizatriptan is an excellent candidate for fast dissolving oral films that can bypass part of first?pass metabolism and provide faster onset

Superdisintegrants such as sodium starch glycolate (SSG), croscarmellose sodium and crospovidone are widely used to accelerate disintegration by swelling and wicking; however, there is growing interest in natural polymers and mucilages (e.g. isabgol, plant gums) due to their biocompatibility, biodegradability, low cost and regulatory acceptability. Natural gums and mucilages have been used as binders, disintegrants, matrix formers and film?formers, but systematic comparisons with synthetic superdisintegrants in oral films remain limited.

1.1 Aim and objectives

The present study aimed to develop and evaluate fast dissolving oral films of rizatriptan benzoate using HPMC E50 as film?forming polymer and to perform a comprehensive comparison between a synthetic superdisintegrant (sodium starch glycolate) and a natural superdisintegrant (isabgol) with respect to physicomechanical properties, disintegration behaviour and in?vitro drug release. Specific objectives were to:

• Formulate synthetic (SSG?based) and natural (isabgol?based) rizatriptan films by solvent casting.
• Assess drug–excipient compatibility by FTIR and DSC.
• Evaluate physical, mechanical and performance parameters of the films.
• Identify the best performing formulation and compare natural versus synthetic superdisintegrants.

2. MATERIALS AND METHODS

2.1 Materials

Rizatriptan benzoate was used as model antimigraine drug. HPMC E50 served as the primary film?forming polymer; SSG (synthetic) and isabgol (natural) were employed as superdisintegrants. Propylene glycol (PG) was used as plasticizer, aspartame as sweetener, citric acid as saliva?stimulating agent, and suitable flavors and colorants were included as required. All other chemicals and reagents were of analytical grade and used as received.

Table 1 summarizes the main materials used in formulation.

Table 1. Principal materials used in formulation

2.2 Formulation design

Fast dissolving oral films were prepared in two sets: synthetic formulations (FS1–FS10) containing SSG and natural formulations (FN1–FN10) containing isabgol, while keeping drug and polymer base constant. HPMC E50 concentration was selected based on preliminary trials to ensure adequate film strength and flexibility. The concentration of SSG or isabgol was varied within each set to optimize disintegration and mechanical properties.

Representative compositions are given in Tables 5.3 and 5.4 of the dissertation, where each 4 cm² film contained a unit dose of rizatriptan benzoate and different levels of superdisintegrant, plasticizer and other excipients.

2.3 Method of preparation

Films were prepared by solvent casting.

1. HPMC E50 was dispersed in purified water with continuous stirring to obtain a uniform polymer solution.
2. Rizatriptan benzoate was dissolved or dispersed in a suitable portion of aqueous vehicle, along with aspartame, citric acid and flavour.
3. Propylene glycol and the respective superdisintegrant (SSG or isabgol) were added to the polymer solution under stirring to obtain a homogeneous casting solution.
4. The final solution was deaerated, poured onto a leveled glass or Teflon plate, and cast to a predetermined thickness.
5. Films were dried at controlled temperature until constant weight, carefully peeled off, and cut into pieces containing the desired dose.
6. Prepared films were stored in airtight containers protected from light and moisture until evaluation.

2.4 Drug–excipient compatibility studies

Compatibility between rizatriptan benzoate and excipients (HPMC E50, SSG, isabgol and full formulations) was assessed by FTIR and DSC.

• FTIR spectra were recorded for pure drug, drug–polymer physical mixtures, drug with SSG, drug with isabgol, synthetic film, and natural film.
• DSC thermograms were obtained for pure rizatriptan benzoate, drug–HPMC E50 and drug–isabgol mixtures.

The spectra and thermograms (Figures 6.1–6.9) were examined for appearance, disappearance or shifting of characteristic peaks and changes in melting behaviour.

2.5 Calibration curve and assay

A calibration curve for rizatriptan benzoate in pH 6.8 phosphate buffer was prepared by measuring absorbance at 226 nm with a UV–Visible spectrophotometer over a suitable concentration range. The resulting plot was linear and used to determine drug content and in?vitro release (Table 6.1 and Figure 6.10).

2.6 Evaluation of fast dissolving films

All formulations were evaluated according to standard pharmaceutics tests.

1. Appearance and surface characteristics: Films were visually inspected for colour, transparency, homogeneity, surface smoothness and presence of air bubbles or imperfections.
2. Thickness: Film thickness was measured at multiple points using a micrometer screw gauge and expressed as mean ± SD.
3. Weight variation: Individual film units were weighed and compared to mean weight.
4. Folding endurance: A strip of fixed size was repeatedly folded at the same point until it broke; the number of folds required to break was recorded as folding endurance.
5. Surface pH: Films were allowed to swell on the surface of pH?adjusted distilled water, and surface pH was measured using a pH electrode to assess potential irritation.
6. Percentage moisture absorption (PMA) and percentage moisture loss (PML): Films were placed in humidity chambers at specified relative humidities; changes in weight were used to calculate PMA and PML (Tables 6.4 and 6.5).
7. Disintegration time: Films were placed on the surface of simulated saliva or pH 6.8 buffer at 37 ± 0.5 °C, and the time taken for complete disintegration was recorded.
8. Drug content: Film samples were dissolved in suitable solvent and analyzed spectrophotometrically to determine drug content uniformity.
9. Mechanical properties: Tensile strength, percent elongation and other mechanical parameters were measured using a tensile testing apparatus and are reported in Tables 6.6 and 6.7.
10. In?vitro drug release: Dissolution studies were performed in pH 6.8 phosphate buffer, typically using USP apparatus, and samples were collected at predetermined intervals up to at least 10 minutes. Drug release was quantified using the calibration curve. Release data are presented in Tables 6.8–6.11 and Figures 6.11–6.14.

3. RESULTS

3.1 Drug–excipient compatibility

FTIR spectra of pure rizatriptan benzoate displayed characteristic peaks corresponding to indole and triazole functional groups, including stretching bands for N–H, C=N and aromatic C–H. Physical mixtures of drug with HPMC E50, SSG and isabgol, as well as spectra of synthetic and natural films, retained the principal drug peaks without significant shifts or disappearance, indicating absence of strong chemical interaction. DSC thermograms of pure rizatriptan benzoate showed a sharp endothermic peak near the reported melting point (178–180 °C), while drug–polymer mixtures showed only minor broadening or slight shift consistent with physical mixing and polymer dispersion. Collectively, the FTIR and DSC results confirmed compatibility between rizatriptan benzoate and the selected excipients.

3.2 Physicochemical properties of films

Tables 6.2 and 6.3 summarize physicochemical properties of synthetic and natural films, respectively. Both groups produced smooth, flexible, transparent to slightly opaque films with acceptable appearance and without visible defects.

• Thickness and weight: Film thicknesses were within a narrow range suitable for handling, with low standard deviations, reflecting uniform casting; weight variation was minimal for both sets.
• Surface pH: Surface pH values were close to neutral (around pH 6–7) for all formulations, suggesting low risk of mucosal irritation
• Moisture parameters: PMA and PML values (Tables 6.4 and 6.5) indicated moderate hygroscopicity, with natural films showing slightly higher moisture interactions, consistent with hydrophilic nature of isabgol.

3.3 Disintegration time and drug content

Synthetic formulations (FS1–FS10) exhibited disintegration times generally in the range reported in Table 6.4, whereas natural formulations (FN1–FN10) showed faster disintegration in most cases, as seen in Table 6.5. Notably, formulation FN9 demonstrated the shortest disintegration time of approximately 10 seconds, which was substantially faster than the best synthetic formulation. Drug content across all films remained close to theoretical values, with low variability, confirming uniform distribution of rizatriptan benzoate within the films.

3.4 Mechanical properties

Mechanical parameters for synthetic and natural films are presented in Tables 6.6 and 6.7. Both film types showed acceptable tensile strength and folding endurance, indicating that propylene glycol and HPMC E50 produced flexible films resistant to cracking or breaking during handling. Folding endurance values were high (greater than typical minimum requirements), and no significant brittleness was observed in either group. Minor differences in tensile strength and elongation reflected the influence of SSG versus isabgol, but all values remained within pharmaceutical limits.

3.5 In?vitro drug release

In?vitro release profiles of synthetic formulations (FS1–FS5 and FS6–FS10) are detailed in Tables 6.8 and 6.9 and graphically represented in Figures 6.11 and 6.12. Synthetic films achieved high levels of drug release within the first few minutes, though release profiles varied depending on SSG concentration.

Natural formulations (FN1–FN5 and FN6–FN10) showed rapid and, in many cases, superior drug release, as summarized in Tables 6.10 and 6.11 and Figures 6.13 and 6.14. Formulation FN9, which also had the shortest disintegration time, released approximately 99.39% of rizatriptan benzoate within 5 minutes, demonstrating very rapid dissolution performance. Overall, natural films demonstrated slightly faster and more complete drug release than their synthetic counterparts at equivalent time points.

4. DISCUSSION

The present study successfully developed fast dissolving oral films of rizatriptan benzoate using HPMC E50 as matrix polymer and either SSG or isabgol as superdisintegrants. Solvent casting produced thin, flexible films with good appearance and mechanical integrity, consistent with previous reports on HPMC?based fast dissolving strips.[58–62] FTIR and DSC data confirmed that rizatriptan benzoate remained chemically stable in presence of both synthetic and natural excipients, which is critical for ensuring efficacy and safety.

Films from both groups exhibited uniform thickness, weight and drug content, indicating that the casting process and formulation design were robust. Surface pH values near neutrality and absence of visual irritation?prone characteristics suggest that the films should be well tolerated in the oral cavity. Moisture uptake and loss were modest; slightly higher moisture interactions in isabgol films likely reflect the hydrophilic and swellable nature of natural mucilages, which is beneficial for rapid disintegration but requires proper moisture?protective packaging.

Superdisintegrants play a crucial role in determining disintegration time and subsequent dissolution. SSG, a cross?linked carboxymethyl starch, promotes disintegration primarily by rapid swelling, whereas isabgol (psyllium husk) contains highly swellable arabinoxylan mucilage capable of forming a gel?like network upon wetting. In this study, isabgol?based formulations generally disintegrated faster than SSG?based films at comparable loadings, with FN9 achieving a disintegration time of 10 seconds, which is highly desirable for fast dissolving films. The rapid disintegration can be attributed to the strong wicking and swelling capacity of isabgol, which disrupts the film matrix quickly upon contact with saliva.

In?vitro release studies further demonstrated that natural superdisintegrant?containing films provided faster and more complete rizatriptan release than synthetic films, again exemplified by FN9 with 99.39% release at 5 minutes. For an antimigraine agent where rapid onset of action is critical, this performance offers clear therapeutic advantages, potentially leading to faster relief and improved patient satisfaction. These findings align with broader literature that natural gums and mucilages can act as effective disintegrants and matrix modifiers in oral formulations while offering additional advantages such as renewability, biocompatibility and low cost.[45–50]

Mechanical properties remained acceptable for both sets, indicating that replacing SSG with isabgol did not compromise film strength when HPMC E50 and propylene glycol were appropriately balanced. This is important from a manufacturing and packaging standpoint, as films must withstand cutting, handling and transport without damage.

Taken together, the data support the conclusion that natural isabgol is a promising alternative to synthetic SSG in rizatriptan benzoate fast dissolving films. The combination of rapid disintegration, near?complete drug release within minutes and acceptable mechanical characteristics makes FN9 a strong candidate for further development and clinical evaluation.

5. CONCLUSION

Fast dissolving oral films of rizatriptan benzoate were successfully formulated using HPMC E50 and evaluated for a wide range of physicochemical and performance parameters. Both synthetic (SSG?based) and natural (isabgol?based) superdisintegrant systems produced pharmaceutically acceptable films; however, isabgol?containing formulations, particularly FN9, showed markedly faster disintegration (10 seconds) and almost complete drug release (99.39% in 5 minutes) compared with SSG?based films. Drug–excipient compatibility studies confirmed the stability of rizatriptan in both matrices, and mechanical testing verified adequate flexibility and strength

These results suggest that natural isabgol is an effective and potentially superior superdisintegrant to SSG in rizatriptan fast dissolving films, offering rapid onset of action, patient?friendly administration without water, and the additional advantages of a natural, biodegradable excipient.[45–50] Further in?vivo studies are warranted to confirm the pharmacokinetic benefits and clinical performance of the optimized natural formulation (FN9) in comparison with conventional oral dosage forms and synthetic?based films.

6. Tables

Table 2. Summary of key physicochemical properties of synthetic vs natural films

Table 3. Mechanical properties of synthetic and natural films

Table 4. In?vitro drug release performance

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