Modified polysaccharides as fast disintegrating excipients for orodispersible tablets of roxithromycin.
The purpose of this study was to develop a dosage form that was easy to administer and provides rapid release of the drug roxithromycin, using modified polysaccharides as rapidly disintegrating excipients. Modified polysaccharides co grinded treated agar (C-TAG) and co grinded treated guar gum (C-TGG) were prepared by subjecting pure polysaccharides namely agar and guar gum respectively to sequential processes of wetting, drying and co grinding with mannitol (1:1). The modified polysaccharides were characterized by Scanning Electron Microscopy and Diffuse Reflectance Spectroscopy and evaluated for particle size distribution, derived properties, swelling index and biodegradability. Optimization studies based on 2(2) factorial designs, with friability and disintegration time as response parameters were used to formulate orodispersible tablets of roxithromycin and evaluated for wetting time, water absorption ratio and in vitro drug release at salivary pH 6.4 and physiological pH 7.4. Results indicated that lower levels of modified polysaccharides namely C-TAG in F(3) and C-TGG in F(7) and higher levels of microcrystalline cellulose, exhibited least disintegration times without friability concerns. In vitro release of optimized formulations F(3) and F(7,) both at salivary pH and physiological pH was found to be more than 90% within 30 min as compared to 27.82% at the same time point of conventional formulation. Stability studies carried out as per ICH Q1A guidelines suggested the formulations to be stable for a period of 6 months. Thus the approach of using modified polysaccharides as fast disintegrating excipient can be used to formulate a stable orodispersible formulation.
Sharma
Vijay
V
Department of Pharmaceutics, Rajiv Academy For Pharmacy, NH#2, Delhi-Mathura bypass, PO Chattikkara, Mathura, 281001 Uttar Pradesh, India.
Philip
Anil K
AK
Pathak
Kamla
K
D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods; D015195:Drug Design; D004353:Drug Evaluation, Preclinical / Q000379:methods; D005079:Excipients / Q000737:chemistry*; D011134:Polysaccharides / Q000737:chemistry*; D015575:Roxithromycin / Q000008:administration & dosage / Q000737:chemistry*; D013607:Tablets
D000900:Anti-Bacterial Agents; D004337:Drug Carriers; D005079:Excipients; D011134:Polysaccharides; D013607:Tablets; D015575:Roxithromycin