Formulation Development of Fixed Dose Combination of Metoprolol Succinate Extended Release Pellets and Atorvastatin Calcium Immediate Release Drugs

摘要

ABSTRACT The main objective of current research work was to develop a stable pharmaceutically equivalent combined dosage form of immediate release Atorvastatin calcium and extended release Metoprolol succinate formulation, which is comparable to that of innovator’s. Combination therapy affords the physician and the patient the opportunity to more effectively treat diseases that may stem from more than one cause. When used correctly and appropriately, combination therapy leads to better outcomes than mono therapy by treating more than one cause of the disease and/or by synergistically enhancing the action of one of the component drugs. The purpose of the study was to develop a capsule of Atorvastatin calcium (IR) and Metoprolol succinate (ER) having different release pattern, which is indicated for the management of hypertension. The study was planned in three stages. In the first stage three batches (A1, A2, and A3) of immediate release blend of Atorvastatin calcium was prepared using pre-gelatinized starch as super disintegrate. In the second stage, nine batches (M1-M9) of Metoprolol succinate sustained release pellets were prepared using various polymers and levels of coatings as rate retardants. Preformulation studies were performed after granulation. In the third stage capsules were evaluated for weight variation, drug content, and disintegration time and in vitro drug release using RP-HPLC. FTIR studies revealed no disturbances in the principle peaks of pure drugs and it confirms the integrity and compatibility of pure drugs with their excipients. Keywords: Atorvastatin calcium, Metoprolol succinate, Coating, Pellets and HPLC.