FORMULATION DEVELOPMENT AND EVALUATION OF RANITIDINE HYDROCHLORIDE TABLETS 150 MG
Prativa Das*, Ch. Niranjan Patra, Deepak Kumar Sarangi, Sasmita Padhy and Soumya Stuti Pattnaik
ABSTRACT
Ranitidine Hydrochloride is a antihistaminic drug and H2 antagonists which is a competitive inhibitors of histamine at the parietal cell H2 receptor. It suppress the normal secretion of acid by parietal cells and the meal-stimulated secretion of acid. The present research work involves the formulation development and evaluation of Ranitidine Hydrochloride Immediate Release tablets. The final optimized formulation contains microcrystalline cellulose (Avicel PH 112) as diluents, Croscarmellose sodium (Ac-di-sol-SD-711) as disintegrant in intragranular part and magnesium stearate, calcium stearate as lubricants in extragranular part in the optimized batch. Ranitidine Hydrochloride immediate release tablet disintegrate within 15 mins for the treatment of Peptic ulcer. As Ranitidine Hydrochloride is a moisture sensitive drug, direct compression method was selected for the formulation of Ranitidine Hydrochloride IR tablets. Among the 10 trials, trial 3 (0.75% magnesium stearate of Peter Greven, 1% Croscarmellose sodium) and trial 9 (1% Calcium stearate,1% Croscarmellose sodium) showed the very close DR profile and having higher f2 values followed by magnesium stearate of Peter Greven vendor at 0.75% concentration showed better results in lower concentration than 1% Calcium stearate. All the trials produce tablets meeting all the product specifications like thickness, hardness, weight uniformity, appearance and the tablets compression challenges such as chipping, capping, sticking, picking, and lamination are no where observed.
Keywords: Ranitidine Hydrochloride, Immediate release tablet, Crosscaramellose sodium, Avicel PH102.
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