Design, Preparation and Evaluation of Indomethacin Pellets

INTRODUCTION: ORAL DRUG DELIVERY:Most conventional oral drug products, such as tablets and capsules, are formulated to release the active drug immediately after oral administration, to obtain rapid and complete systemic drug absorption. Such immediate release products result in relatively rapid drug absorption and onset of accompanying pharmacodynamic effects. However, after absorption of the dosage form is complete, plasma drug concentration decline according to drug’s pharmacokinetic profile. Eventually, plasma drug concentration fall below the minimum effective plasma concentration (MEC), resulting in loss of therapeutic activity. Before this point is reached, another dose is usually given if a sustained therapeutic effect is desired. An alternative to administering another dose is to use a dosage form that will provide sustained drug release, and therefore maintain plasma drug concentrations, beyond what is typically seen using immediate release dosage forms. MODIFIED DRUG DELIVERY: The term modified release drug product is used to describe products that alter the timing and/or the rate of release of the drug substance. A modified-release dosage form is defined as one for which the drug-release characteristics of time course and/or location are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as solutions, ointments, or promptly dissolving dosage forms as presently recognized. Several types of modified-release drug products are recognized. AIM OF WORK: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) commonly used for the reduction of pain and inflammation caused by condition such as osteoarthritis, gout, ulcerative colitis, colon cancer. Its biological half-life is 4.5 hrs. When given conventionally it gets released in the upper GIT there by causing irritation and ulcer in the upper GIT. The dosage form should be designed in such a way that it should minimize or prevent drug release in the acidic environment of upper GIT and start releasing the drug in a controlled manner once it reaches the alkaline environment of small intestine. Aim of the present work is to formulate the indomethacin pellets to present it in the form of capsules (Extended release pellets).To develop and over an extended period of time in the gastro intestinal track and compared the in-vitro dissolution profile with that of the marketed product.OBJECTIVES: 1.Reduced frequency of dosage form 2. Improved patient compliance 3. Maximizing bio availability with a minimum dose 4. To study the release profile of the formulation using various polymer CONCLUSION: The present work was carried out to design and evaluate Indomethacin capsules containing extended release pellets. Indomethacin is a NSAID and is one of the most widely used drug for treating mild and severe pains. The combination of ethyl cellulose and other polymers the drug release rate increased due to a formation of a porous on the pellets. Formulation F-5 (containing ethyl cellulose 5% w/w and hydroxypropyl cellulose 9%w/w) showed better release profile i.e. very low initial drug release in the first two hrs and afterwards the rate of drug release increased with almost complete release of the drug being achieved in 97.03% at 24 hrs respectively. Hence F-5 release profile was passed all USP test-1 limits and further continuous for kinetic study and stability studies. Pellets technique using ethyl cellulose as the retardant has successfully extended the release of indomethacin from its pellets formulations. In the present study, it was found that incorporation of hydroxypropyl cellulose in the pellets not only helped to provide good initial retardation in the release but also helps to enhance the overall release rate of the drug after a suitable lag time and also it will act as suitable binding property. The result of formulation (F-5) evaluation indicated that the dissolution profile of optimized formulation was comparable to the dissolution profile of marketed sample. It shows better release compared to market product. Optimized formulation F-5 was subjected to data obtained from stability studies indicate that there is no much change in the release profile and drug content of pellets. Hence the prepared pellets of formulation (F-5) were found to be stable.