FORMULATION AND IN-VITRO PHYSICOCHEMICAL EVALUATION OF GLYCEROL-PLASTICIZED PVA/PVP FAST DISSOLVING ORAL STRIPS CONTAINING RABEPRAZOLE AND METOCLOPRAMIDE
Keywords:
Fast Dissolving Oral Strips (FDOSs), Rabeprazole Sodium, Metoclopramide Hydrochloride, Polyvinyl Alcohol (PVA), Glycerol Plasticization, and Mechanical Properties.Abstract
Background: Gastroesophageal reflux disease (GERD) is a common gastrointestinal condition that has a great impact on patients' quality of life. The tablets/capsules are the conventional dosage forms that tend to have a delayed therapeutic effect and may be subjected to degradation in the highly acidic stomach environment. The objective of this study is to develop and systematically test a fast dissolving oral strip containing two different drugs: proton pump inhibitor (Rabeprazole Sodium) and prokinetic agent (Metoclopramide Hydrochloride) with the goal of reducing the first-pass effect in the liver and providing rapid symptom relief.
Methodology: The solvent-film casting method was used for the fabrication of the FDOSs. Polyvinyl Alcohol (PVA) was used as the main film forming polymer with Polyvinyl Pyrrolidone (PVP K30) as an optimum polymer for film elasticity. Glycerol was tested as a plasticizer at 5, 7.5 and 10% w/w. The preformulation compatibility was evaluated using Fourier Transform Infra Red Spectroscopy (FTIR). The strips produced were extensively tested for their surface morphology, mechanical properties (tensile strength, elongation, Young's modulus), weight uniformity, pH uniformity, moisture content, and in-vitro disintegration time (D.T), total dissolution time (T.), and time at which the gas reaches 100% (t.The percentage drug content, D), and percentage yield.
Results and Discussion: The FTIR spectra indicated that the structure and chemical compatibility of both the drugs remained intact in the polymeric matrix. The optimized strips presented a surface morphology with light microscopy without the presence of any stickiness. Mechanical testing showed that the higher the concentration of glycerol, the lower the brittleness of the film, and the most ideal mechanical properties are obtained when the glycerol concentration is 75%. All formulations had an acceptable range for oral mucosa pH (6.38–6.92) and rapid disintegration (<30 seconds) to release the therapeutic doses.
Conclusion: Glycerol-plasticized PVA/PVP fast-dissolving oral strips are a stable, mechanically sound and highly patient-friendly option for GERD treatment compared to conventional treatment.
