ABSTRACT

Due to necessities their affordable manufacturing costs and simplicity of administration, especially in controlled-release applications, tablet dosage forms have traditionally been chosen over other formulations for oral medication delivery. Over monotherapy, combination therapy has a number of benefits. The pharmaceutical industry has grown more interested in recent years in creating dosage forms (monolithic, bilayer, or multi-layered tablets) that combine two or more Active Pharmaceutical Ingredients (API), improving patient convenience and compliance. The active pharmaceutical ingredient (API) is delivered from controlled-release tablets over an intended or prolonged period of time after oral administration. This may allow for a reduction in peak plasma concentrations and dose frequency, which enhances patient compliance while lowering the likelihood of unfavorable side effects. To transfer APIs into the body, conventional single-layered matrix tablets have been widely used. These traditional single-layered matrix tablets, however, have less than ideal delivery characteristics, such as non-linear drug release profiles that could result in more side effects. A multi-layered technology has recently been created to expand upon or replace the single-layered tablet's constraints. With the use of this technology, pharmaceutical businesses may have a better chance of creating new medications and improving their life cycle management. An overview of multi-layered tablets is provided in this article, with particular attention paid to manufacturing challenges, different tablet designs, and drug release profiles. This article covers the necessity for quality Multi-layered Tablet development and production, as well as the present state of the market.

Keywords: Multi-layered Tablet, controlled-release tablets, monolithic, matrix tablets

ABSTRACT

Rare diseases are a major public health problem and public health challenge. Orphan drugs are medicines intended to diagnose, prevent, or treat life-threatening rare diseases. In a country like India, which is already struggling to provide basic healthcare facilities to its large population, it becomes very difficult for people living with rare diseases to access treatment options. The orphan drug legislation provides the pharmaceutical industry with a set of incentives and conditions to develop drugs for the treatment of rare diseases. The aim of this article is to describe orphan drugs for the treatment of rare diseases, Legislation, Indian Perspectives, Access to Orphan Medicines, Designation, Progress and Sales. Orphan drugs can help pharmaceutical companies reduce the impact of lost sales caused by blockbuster drug patent expirations. In our study we compare essential drugs with orphan drugs and examine approaches and future prospects in the development of orphan drugs. 

Keywords: Rare Diseases, Orphan Drugs, Essential Medicines, Orphan Drug Act, NPRD, Advancements in Research.