Modified Release Formulations to Achieve the Quality Target Product Profile (qtpp)

Modified Release (MR) Formulations have a modification in the release mechanism. Modified release dosage forms are developed by altering drug absorption or the site of drug release in order to achieve predetermined clinical objectives. Modified drug release from dosage forms is complemented by the allied processes of drug design, of dosage administration, and of membrane transport and absorption of drug to the biological site of action. Modified-release drugs have complex formulations that can offer an advantage over standard medication for some patients. Modified-release preparations should only be used where there is a clear clinical advantage over conventional-release preparations. In general, Modified-release preparations should be reserved for specific patients where there is a problem with compliance, effectiveness or side-effects which these preparations could help overcome. Modified–release technologies have become indispensable to resolving critical technical, therapeutic, and marketing challenges, such as improving patience compliance, less dosage timings, better safety, better indications, delivering poorly soluble and poorly absorbable API’s, product differentiation, patent protection, product lifecycle extension, and better margins. Modified-release formulation design can be conducted for oral and non-oral administration routes. Possible therapeutic benefits of an MR product include improved efficacy and reduced adverse events, increased convenience and patient compliance, optimized performance, a greater selectivity of activity, or new indications. INTRODUCTION: The goal of any drug delivery system is to provide a therapeutic amount of drug to the proper site in the body to achieve promptly and then maintain the desired drug concentration . Advances in molecular biology, and of physiological and disease processes, often identify opportunities for improving the performance of a medication. Performance enhancement might concern providing more options for administration, less frequent administration or simply providing medication that is more acceptable to the user. Possibilities also exist, depending on the kinetics and dynamics of drug action, and its dose– response relationships for improving efficacy or reducing side effects. Indeed the drug delivery system employed plays a vital role in controlling the pharmacological effect of the drug as it can influence the pharmacokinetic profile of the drug, the rate of drug release, the site and duration of drug action and subsequently the side-effect profile. An optimal drug delivery system ensures that the active drug is available at the site of action for the correct time and duration.