Preparation Of Oral Fast Dissolving Films Of Amitriptyline Hydrochloride

Objectives:To screen the optimized formulation and film-forming condition of oral fast dissolving films(OFDF)of amitriptyline hydrochloride and evaluate its preliminary quality.Methods:At first,preformulation studies of amitriptyline hydrochloride were carried out,including observation of the appearance and crystal forms using microscope,X-RD and DSC,respectively.The solubility of drug and O/W partition coefficient were determined,the measurement method drug content was established and validated,too.Meanwhile,the stress test in different condition and enhanced degradation trials were performed.Then,the formulation and preparing process of OFDF of amitriptyline hydrochloride were investigated systemically.The composition of empty OFDF was investigated.After that,the effect of plasticizers,disintegrants,permeation enhancers and preparation process on the physicochemical properties of amitriptyline hydrochloride-loaded OFDF were evaluated.Finally,the pharmaceutical characterization of amitriptyline hydrochloride-loaded OFDF were conducted such as appearance,difference degree limitation of films weights and physical structures,etc.Results: The crystalline shape of amitriptyline hydrochloride displayed like strips.The raw material showed easily water soluble with an appropriate oil/water partition coefficient(Log P= 1.21).The HPLC determination method of amitriptyline hydrochloride was stable and reliable.Amitriptyline hydrochloride has good stability in various stressed conditions including temperature,humidity,illumination,strong acid & basic solution and oxidants.The formulation and preparation process of OFDF were determined based on the film thickness,disintegration time and elastic modulus.An OFDF(1.5cm×2.0cm)composed of 15 mg amitriptyline hydrochloride,16 mg HPMC and 0.4mg HA as film forming material,5.4mg PEG-400 as plasticizer,0.8mg PS as disintegrating agent and 3% propylene glycol as penetration enhancer.The OFDF was dried at 60?for 2 hours.The appearance and weight variation test of amitriptyline hydrochloride OFDF meet the criteria of “Chinese Pharmacopoeia”.Conclusion:The formulation and preparation process of amitriptyline hydrochloride OFDF were established,the preliminary quality control test was performed.The present study could provide beneficial experiment evidences for the follow-up research & development of amitriptyline hydrochloride OFDF.