DESIGN, DEVELOPMENT, AND CHARACTERIZATION OF OROMUCOSAL WAFER OF TRAMADOL HYDROCHLORIDE

Rita N Wadetwar; Tejaswini Charde

doi:10.22159/ajpcr.2018.v11i8.25709

Authors

Rita N Wadetwar Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj, Nagpur University, Nagpur, Maharashtra, India.
Tejaswini Charde Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj, Nagpur University, Nagpur, Maharashtra, India.

DOI:

https://doi.org/10.22159/ajpcr.2018.v11i8.25709

Keywords:

Wafers, Tramadol HCl, pullulan, Solvent casting method

Abstract

Objective: The objective of the present work was the preparation of fast-dissolving film of tramadol HCl (TMH) using water-soluble polymer, to achieve faster onset of action, to improve patient compliance, ease of dosing, and bypass the first-pass metabolism.

Methods: TMH oromucosal wafers were prepared using pullulan as natural, biodegradable polymer, and propylene glycol as plasticizer by solvent casting method. Formulation batches were prepared using 32 full-factorial designs. The prepared TMH oromucosal wafers were characterized for morphology, uniformity of weight, drug content, folding endurance, in vitro disintegration time (DT), % moisture content, surface pH, in vitro % drug release, ex vivo permeation studies, compatibility studies (differential scanning calorimetry, Fourier transform infrared spectroscopy, and X-ray diffraction), and stability studies.

Results: Optimized batch of mouth-dissolving film of TMH containing pullulan as polymer showed 98.67Â±0.11% drug release at 6 min. It showed better folding endurance 88 No. of folds, in vitro DT 5.11 s, surface pH 6.84Â±0.12 pH, thickness 0.17Â±0.11 mm, and percentage content uniformity 98.45Â±0.48%. Stability studies carried out for the best formulation FDF5 revealed that the formulation was stable.

Conclusion: The results obtained in this research work clearly indicated a promising potential of fast-dissolving oral films using natural biodegradable polymer, pullulan which gave rapid drug delivery and rapid onset of action of centrally acting drug, TMH for patients suffering from pain.

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Author Biographies

Rita N Wadetwar, Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj, Nagpur University, Nagpur, Maharashtra, India.

University Department completed 60 years

Tejaswini Charde, Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj, Nagpur University, Nagpur, Maharashtra, India.

University Department completed 60 years

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