Solid Dispersion with innovative Sintering Technique in Pharmaceutical Industry: An Ultimate Solution for development of dosage form of Poorly Aqueous Soluble Drugs

Abstract

The Solubility of poorly water soluble drug have critical impact on drug dissolution and their absorption.  Most of the newly discovered drugs have poor or very limited aqueous solubility, causes a serious challenge to the successful development & commercialization of new drug product or dosage form in the pharmaceutical industry. Numbers of techniques are available for the solubility enhancement but all individual techniques have its own limitations during its commercialization. A well-known Solubility enhancement technique like Solid dispersions provides dispersion of poorly soluble drug in a suitable inert carrier at a molecular level and form amorphous and highly soluble compounds. The conversion of crystalline compound in to amorphous form or reduction of particle size to its molecular level caused enhanced solubility of poorly soluble by the application of solid dispersion techniques. Although, Solid dispersion has vast potential, but only limited products are commercialized and reported in different literatures due to its poor scalability and low mechanical strength of solid dosage forms like Tablets. Hence, an innovative Sintering technique in combination of solid dispersion produces high mechanical strength and easy scalability in pharmaceutical industry. The sintering is expressed as the joining of adjacent particles in a mass of powder, or in tablets, by the heat application. Conventional sintering technique involves heating of compact mass at a temperature below the melting point of the available solid constituents in controlled environments. The sintering technique with solid dispersion technique has manifold advantages over traditional dry or wet granulation method like minimum quantity of drug polymer ratio,easy tailoring of drug release profile, cost effective, high mechanical strength of dosage forms. Sintering concept not only improves mechanical strength of dosage form, but it also controls the release of medicament on over an extended time period.