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Abstract

DEVELOPMENT, CHARACTERISATION AND PRECLINICAL EVALUATION OF SOME NOVEL ENZYMES WITH VITAMIN

Amol S.Rakte*, Dr. Basavaraj K.Nanjwade

ABSTRACT

Aim of the present research was to formulate and evaluate a multienzyme (Bromelain, Papain, Bacterial Protease, Rutin) with Vitamin C effervescent tablet with sufficient mechanical integrity, good palatability, robust formulation, good stability, inexpensive and shop floor friendly product produced in normal thermo-hygrometric conditions. In the preformulation study, identification of each enzymes were done with the help of MALDI-TOF instrument and compatibility evaluation was performed which implies that drug and excipients were compatible with each other. The formulations of tablets were done by using different methods like wet granulation, dry granulation and direct compression. Total ten trials for each method was prepared and evaluated for hardness, friability, effervescent time, weight variation, and pH. Finally one batch from each method having good physical parameters was kept for stability {DC-6 (direct compression) DG-7(dry granulation) and WG-8(wet granulation)}. From that techniques stability of tablets with wet granulation method was found to be satisfactory than other methods. The preclinical evaluation of this composition study has been undertaken to investigate the anti-inflammatory and toxicity studies in laboratory animals (Albino Wistar Rats).The main method used for Anti-inflammatory was Carrageenan induced paw edema and for toxicity studies OECD 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents) and OECD 425 (Acute Oral Toxicity – Up-and-Down Procedure).

Keywords: Effervescence, Enzyme Premix, OECD, MALDI-TOF, Carrageenan induced paw edema.


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