Abstract
Purpose: To prepare and characterize orally disintegrating films (ODFs) of promethazine hydrochloride (HCl) for prompt treatment of motion sickness.Methods: Films were prepared by solvent casting method using hydroxypropyl cellulose (HPC) as film former and glycerin as plasticizer along with a saliva stimulating and sweetening agent. Nine different film formulations were prepared and evaluated for their characteristics including thickness, disintegration time, tensile strength and drug release behavior.Results: The prepared films were transparent and slightly sticky in nature with thickness that ranged from 0.22 mm to 0.29 mm and tensile strength of 0.56 N/cm² to 2.49 N/cm². The disintegration time of film formulations ranged from 26.3 to 52.7 s and a majority of formulations released approx. 80 % of the drug within 10 min with a non-Fickian diffusion pattern.Conclusion: The study concludes that the orally disintegrating films of promethazine HCl can be prepared using HPC as film former.Key words: Orally disintegrating films, Promethazine, Solvent casting, Motion sickness
Highlights
Tablets and capsules are most preferred dosage forms for drug delivery due to their ease of administration, accurate dosage and portability [1]
The screening trials indicated that the films of hydroxypropyl cellulose (HPC) alone were not peelable from the petri dish or aluminium foil and were too brittle (Figure 1A)
The films prepared by incorporating the plasticizer were transparent, flexible, slightly sticky in nature and peel-able (Figure 1B)
Summary
Tablets and capsules are most preferred dosage forms for drug delivery due to their ease of administration, accurate dosage and portability [1]. Promethazine HCl is a selective histamine H1receptor antagonist, an effective drug approved by FDA in 2009 for the treatment of motion sickness [6]. Initial screening studies were conducted to determine the minimum and maximum concentration of HPC (films forming polymer) and glycerin (plasticizer). In the preparation of drug loaded films; HPC was dissolved in 10 mL of distilled water with stirring and the drug is added in this polymeric solution and continuously stirred for 30 min to obtain a clear solution. Glycerin was added in the HPC/drug solution and stirred to make clear solution
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