Development and Characterization of Gel-Based Buccoadhesive Bilayer Formulation of Nifedipine
Author:
Alagusundaram M.1ORCID, Jain Nem Kumar2ORCID, Begum M. Yasmin3ORCID, Parameswari S. Angala4, Nelson Vinod Kumar5, Bayan Mohammad F.6ORCID, Chandrasekaran Balakumar6ORCID
Affiliation:
1. Department of Pharmaceutics, School of Pharmacy, ITM University, Gwalior 474001, Madhya Pradesh, India 2. Department of Pharmacology, School of Pharmacy, ITM University, Gwalior 474001, Madhya Pradesh, India 3. Department of Pharmaceutics, College of Pharmacy, King Khalid University, Abha 61421, Saudi Arabia 4. Department of Pharmaceutical Analysis, Jagan’s Institute of Pharmaceutical Sciences, Nellore 524346, Andhra Pradesh, India 5. Department of Pharmaceutical Chemistry, Raghavendra Institute of Pharmaceutical Education and Research, Anantapuramu 515721, Andhra Pradesh, India 6. Faculty of Pharmacy, Philadelphia University, P.O. Box 1, Amman 19392, Jordan
Abstract
A promising controlled drug delivery system has been developed based on polymeric buccoadhesive bilayered formulation that uses a drug-free backing layer and a polymeric hydrophilic gel buccoadhesive core layer containing nifedipine. The DSC thermogravimetric analysis confirms the drug’s entrapment in the gel layer and reveals no evidence of a potential interaction. Various ratios of bioadhesive polymers, including HPMC K100, PVP K30, SCMC, and CP 934, were combined with EC as an impermeable backing layer to ensure unidirectional drug release towards the buccal mucosa. The polymeric compositions of hydrophilic gel-natured HPMC, SCMC, and CP formed a matrix layer by surrounding the core nifedipine during compression. Preformulation studies were performed for all of the ingredients in order to evaluate their physical and flow characteristics. Ex vivo buccoadhesive strength, surface pH, swelling index, in vitro and in vivo drug release, and ex vivo permeation investigations were performed to evaluate the produced gel-based system. Rapid temperature variations had no appreciable impact on the substance’s physical properties, pharmacological content, or buccoadhesive strength during stability testing using actual human saliva. It was clear from a histological examination of the ex vivo mucosa that the developed system did not cause any irritation or inflammation at the site of administration. The formulation NT5 was the best one, with a correlation coefficient of 0.9966. The in vitro and in vivo drug release profiles were well correlated, and they mimic the in vitro drug release pattern via the biological membrane. Thus, the developed gel-based formulation was found to be novel, stable, and useful for the targeted delivery of nifedipine.
Funder
King Khalid University
Subject
Polymers and Plastics,Organic Chemistry,Biomaterials,Bioengineering
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