ABOUT AUTHORS: Mohalkar Rahul1*, Poul Bhagwat2, Patil S.S1, Shetkar M.A1, Dilip Chavan1 1 Department of Quality Assurance, Maharashtra College of Pharmacy, Nilanga 2 Principal of Maharashtra College of Pharmacy, Nilanga,
Latur, Maharashtra, India. *rahulmohalkar@gmail.com
ABSTRACT:
The oral drug delivery system which includes the solid dosages form such as conventional dosages form and immediate release dosages form. Form last several decades conventional dosage forms like capsule, solid, pills, powder, solution, emulsion, suspension aerosols are used in the various treatments of acute or chronic disease. Today this formulation can be considered as primary pharmaceutical product are mostly seen in overalls market. Tablet is most popular among the all dosages forms today and recently found mostly accepted tablet dosages forms. Because of its convenience easy to administration, convenience of self administration, compactness and easy for the manufacturing. In number of cases immediate onset of action is required than conventional therapy. The basic approach used in development immediate release solid dosages form by using superdisintegrant like sodium starch glycolate (Primogel, Explotab), Polyvinylpyrrolidone (PVP) etc. which provides in instantaneous disintegration of tablet after administration. By using various techniques in can be formulate like wet granulation, direct compression etc. Hence its having A new dosage form allows a manufacturer to extend market exclusivity, while offering its patient population a more convenient dosage form or dosing regimen.
ABOUT AUTHORS: Anilkumar S. Chinchole1*, B.N.Poul2, C.V. Panchal1, D.V. Chavan1 1Department of Quality Assurance, Maharashtra College of Pharmacy, Nilanga, Latur, Maharashtra, India 2Principal of Maharashtra College of Pharmacy, Nilanga
Maharashtra College of Pharmacy, Nilanga, Latur, Maharashtra, India *anilc14@gmail.com
ABSTRACT
Stability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and consistency for new drug and pharmaceutical dosage form. The brief understanding of these guidelines can be easily recognized by this article. Stability testing Provide a evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. To establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Because physical, chemical or microbiological changes might impact the efficiency and security of the final product. To minimize the Adverse Effects Of Instability In Drug Products Loss of potency of drug such as Change in concentration of active drug, Alteration of bioavailability, Loss of content uniformity, Loss of pharmaceutical elegance and patient acceptability, Formation of toxic degradation products.