Quality Evaluation Of Oral Fast Dissolving Films Of Amitriptyline Hydrochloride

Objectives:In order to evaluate the formulation and preparation method of Oral Fast Dissolving Film of Amitriptyline Hydrochloride?AMTL-OFDF?,the quality assay and preliminary stability test were carried out.Methods:Based on the previous established formulation,solvent casting method was used to prepare AMTL-OFDF.According to the guidelines from“Chinese Pharmacopeia”(15^th version,No.0125),the pharmaceutical characterization and quality assay studies of AMTL-OFDF were performed.In present study,we observed the appearance,thickness,disintegration time,elasticity modulus,drug content,weight variation,moisture content and dissolution profiles of AMTL-OFDF.The preliminary stabilities of AMTL-OFDF were conducted under stressed conditions,including high temperature,high humidity and strong light conditions for 10 days.The moisture absorption AMTL-OFDF was measured,too.Results:Low molecular weight hydroxypropyl methyl cellulose?HPMC E5,1.2 g?and Hyaluronic acid?HA,30 mg?were used as film forming materials in AMTL-OFDF.Polyethylene glycol 400?PEG 400,400 mg?and pregelatinized starch?PS,60 mg?were employed for plasticizer and disintegrants,respectively.Propylene glycol?3%?was used as permeation enhancer.The ingredients of formulation were homogeneously blended,dissolved in appropriate amount of deionized distilled water,and casting onto stainless steel mold?15 cm×15 cm?,followed by oven drying at 60 ^oC for 2 hours to obtain AMTL-OFDF.AMTL-OFDF displayed light yellow color,transparent or opaque,with almost uniform thickness and smooth surface,no apparent bubble accompany with sufficient flexibility.The thickness and weight of AMTL-OFDF were 90¹20?m and 24.3±0.9 mg?CV=3.61%?,respectively.The content of AMTL,disintegration time and average elasticity modulus of AMTL-OFDF 5.9⁸.2 mg,26.0³7.0 seconds and150.4¹83.0 Mpa,all the parameters close to parameters we expected.The moisture content of AMTL-OFDF was 5.87±0.75%?w/w?and accorded with the requirement?<12%?.The dissolution of AMTL from OFDF was significantly faster than the marketed sugar coating and film coating tablets.The results of X-ray powder diffraction?XR-PD?confirmed the amorphous state of AMTL in OFDF.FT-IR assay showed the potential interaction between AMTL and excipients.The stability test of AMTL-OFDF under stressed condition showed the relative high sensitivity of OFDF to humidity,temperature and light.Hence,this kind of dosage form?OFDF?should be preserved and transported in shade,dark and tight condition,especially avoid the influence of environmental humidity.Conclusion:The preliminary studies of quality assay and stability test were conducted.These results will provide valuable evidences to the further formulation research,process optimization and quality control establishment of AMTL-OFDF.