DESIGN, DEVELOPMENT, AND CHARACTERIZATION OF OROMUCOSAL WAFER OF TRAMADOL HYDROCHLORIDE
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2018, Vol 11, Issue 8
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 98.67±0.11% drug release at 6 min. It showed better folding endurance 88 No. of folds, in vitro DT 5.11 s, surface pH 6.84±0.12 pH, thickness 0.17±0.11 mm, and percentage content uniformity 98.45±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.
Authors and Affiliations
Rita N Wadetwar, Tejaswini Charde
Keywords
Related Articles
- EP ID EP567316
- DOI 10.22159/ajpcr.2018.v11i8.25709
- Views 138
- Downloads 0
EFFECT OF ISOMETRIC AND ISOTONIC EXERCISE TRAINING ON CORE MUSCLE IN SUBJECTS WITH NON SPECIFIC LOW BACK PAIN
Objective: To compare the effects of isometric (stability) and isotonic training on core muscle in patients with non-specific low back pain on pain, endurance, and functional disability.Methods: Forty participants of bot...
ANTIMICROBIAL AND CHITINASE INHIBITORY ACTIVITIES OF 7-BENZAMIDOCOUMARINS
Objective: The aim of this study was to examine in vitro antimicrobial activity of a series of 7-benzamidocoumarin derivatives against three Gram-positive bacteria (Bacillus subtilis, Staphylococcus aureus, and Bacillus...
COMPOSITION OF THE ESSENTIAL OIL FROM MIMOSA PUDICA LINN.
Objectives: To determine the composition of the essential oil obtained from Mimosa pudica L. (Mimosaceae) Methods: The essential oil  of M. pudica was obtained by hydro distillation using a Clevenger apparatus and t...
EVALUATION OF PHYTOCONSTITUENTS, AND ANTIMICROBIAL AND ANTIOXIDANT ACTIVITY OF JUGLANS REGIA FROM KASHMIR REGION
Objectives: The main focus of the present study was to evaluate the antimicrobial efficacy (against oral pathogenic bacteria), free radical scavenging activity, and total phenolic and flavonoids content (TPC and TFC) of...
ANTIOXIDATIVE AND ANTIBACTERIAL POTENTIALS OF FUNGAL ENDOPHYTES FROM JUSTICIA WYNAADENSIS HEYNE: AN ETHNOMEDICINAL RAIN FOREST SPECIES OF WESTERN GHATS
Objective: Endophytes, living within the medicinal plants, are recognized as an alternative source of bioactive components useful for human health. This study aims to isolate and identify the fungal endophytes from the e...