Design Development and Evaluation of Oral Controlled Drug Delivery System for Aceclofenac an Anti Inflammatory Drug

Abstract

Oral drug delivery is the most common and frequently used system to deliver drugs and it is one of the most suitable, convenient, safe, economic and effective way to deliver the drug. Aceclofenac is a drug commonly used in the management of pain and inflammation in various conditions like post-traumatic, cervical and low back pain, ankylosing spondylitis, rheumatoid arthritis and osteoarthritis. This drug, on long term usage, specifically by oral route is reported to cause adverse effects including gastritis. So the situation demands development of safe and effective oral drug delivery system for aceclofenac. To achieve the above goals oral controlled drug delivery systems like Osmotic tablets, Microspheres and Nanosuspensions of Aceclofenac were developed, optimized and evaluated in vitro and in vivo. The preformulation studies were performed for the drug and excipients. The melting point, loss on drying, angle of repose, bulk density, tap density, Hausner s ratio compressibility index were calculated. The flow property studies indicated that the aceclofenac has poor flow properties. newlineCONCLUSION: newlineThe present work was aimed at the development of controlled drug delivery of aceclofenac for oral route. Three dosage forms were developed: Osmotic controlled tablets, Microspheres, Nanosuspension. The osmotic tablets (OT10) contain sodium bicarbonate and sodium chloride s osmogen indicated ideal controlled release of aceclofenac. It released 94.3 ± 0.2% of the drug at the pH 7.4. This formulation do not cause any gastric irritation because, the release of drug on the acidic pH is very low. The therapeutic efficacy will be improved due to the controlled release for 24 hrs. The microspheres containing aceclofenac M4 indicated excellent flow properties when compared with pure aceclofenac. Thus the micronized particles (20±10and#956;m) and higher entrapment efficiency (86.6±0.6%) were achieved. The formulation was stable atleast for 90 days and indicated controlled release for 24 hrs. newline newline