Formulation and Evaluation of Amitriptyline HCL Mucoadhesive Buccal Films

Buccal mucoadhesive systems among novel drug delivery systems have attracted great attention in recent years due to their ability to adhere and remain on the oral mucosa and to release their drug content gradually Buccal mucoadhesive films can improve the drug therapeutic effect by enhancement of drug absorption through oral mucosa increasing the drug bioavailability via reducing the hepatic first-pass effect. The aim of the current study was to formulate the drug as buccal bioadhesive film, which releases the drug at sufficient concentration with a sustained manner reducing the frequency of the dosage form administration. One of the advantages of this formulation is better patient compliances due to the ease of administration with no water to swallow the product. Dissolution profile as studied in USP dissolution apparatus type 1 using pH 6.8 simulated saliva. The influence of variables like polymer type, concentration, of Amitriptyline HCl release profile was studied. The formulation was optimized based on various evaluation parameters like drug content and in-vitro drug release. Formulation F6 successfully release of drug within 7 hrs. The IR spectra showed stable properties of Amitriptyline HCl in a mixture of polymers used and revealed the absence of interaction between drug and selected polymer, stability studies were as per ICH guidelines, and results indicated that the selected formulation was stable. KEYWORDS - Amitriptyline HCL, Mucoadhesive, Buccal films.