World Journal of
Pharmaceutical and Life Sciences

FORMULATION AND EVALUATION OF GLUCOSAMINE SULPHATE POTASSUIM CHLORIDE 1500 MG & DIACEREIN 50 MG FILM COATED TABLET

Jameel Abbas*, Ansari Yaasir Ahmed, Dr. Malik Tauheed Ahmad, Dr. Sayed Isar Ahmad, Sayyed Mukhim, Mohd. Azharuddin

ABSTRACT

Diacerein is a symptomatic slow-acting drug in osteoarthritis with anti-inflammatory, anti-catabolic and pro-anabolic properties on cartilage and synovial membrane. Diacerein shows protective effects against subchondral bone remodelling. Based on a various pharmacological and biopharmaceutical studies and review of clinical trials and meta-analyses, that the efficacy of Diacerein is similar to that of non-steroidal anti-inflammatory drugs (NSAIDs) after the first month of treatment, and superior to that of paracetamol and other NSAID. Additionally, Diacerein has shown a prolonged effect on symptoms of several months once treatment was stopped. The use of Diacerein is associated with common gastrointestinal disorders such as soft stools and diarrhoea, common mild skin reactions, and, uncommonly, hepatobiliary disorders. However, NSAIDs and paracetamol are known to cause potentially severe hepatic, gastrointestinal, renal, cutaneous and cardiovascular reactions. Generally Diacerein 50 mg with Glucosamine are shows the synergistic effect in treatment of osteoarthritis and chronic pain. The consultant and Doctor not prefer the Diacerein in single dose but prefer in combination. In the market the Diacerein is available 50 mg film coated tablet form. Glucosamine is naturally hygroscopic is nature when exposed to air and moisture and degradable whether in the form of tablet or raw material. To overcome this problem Glucosamine needs to bond with suitable stabilizer. Glucosamine Sulphate in the form of Salt i.e. Sodium chloride and potassium chloride are stable. The normal dose of Glucosamine is 500-1500 mg TID. It is very difficult to compress the tablet at the label claim 1500 mg because some additive are also required in the formulation and the average weight are 1800 mg. As per the pre formulation studies it is concluded that tablet average weight less than 70 mg are very difficult to compress and more than 1500 mg are difficult to swallow in adult patient. Glucosamine is a special formulation that prove the pharmacological value to nourish the joint health. Glucosamine stimulates the formation or manufacture of collagen, the protein portion of the fibrous substance that holds joints together and provides a shock-absorbing cushion, as a person ages, the cartilage that cushions the joints often loses its ability to support healthy cellular growth. In addition, the synovial fluid which lubricates these joints also deteriorates. This condition, called osteoarthritis, often leads to rough bones that rub together and cause distress with every twist or bend. In this condition patient regularly required the Glucosamine tablet in 1500 mg three times a day. As per the pre formulation and formulation studies, it is observed that it is very difficult to compress the tablet at huge weight (Glucosamine 1500 mg + Diacerein 50 mg) because D tooling compression machine have maximum limit is 1500 mg. For such critical formulation weight cam is adjusted in lower direction to increase the weight and feeding of granules in feed frame through force feeder resolve the dissolution problem as force feeder required less lubricant and all the lubricant are hydrophobic in nature. This tablet is prepared by wet granulation method by using Non Aqueous binding showed good results physical evaluation parameters and chemical parameters such as Assay, and Dissolution values. The granules lubricated with lubricants / Glidant / Antiadhrants were good in their flow properties. Assay and dissolution studies were conducted by the HPLC method.

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