FORMULATION AND EVALUATION OF GLUCOSAMINE SULPHATE KCL 1500 MG & CHONDROITIN SULPHATE 200 MG FILM COATED TABLET
Jameel Abbas*, Dr. Malik Tauheed Ahmad, Dr. Md. Ashfaque, Dr. Shaikh Muzaffar Ahmad, Dr. Ateequrrahman MD and Dr. Masarat Begum
ABSTRACT
Chondroitin is a component of human connective tissues found in cartilage and bone. In supplements, Chondroitin sulfate usually comes from animal cartilage. Reduces pain and inflammation, improves joint function and slows progression of osteoarthritis (OA). Believed to enhance the shock-absorbing properties of collagen and block enzymes that break down cartilage. Helps cartilage retain water and may reverse cartilage loss when used with glucosamine. The largest study to date, the 2006 Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) looked at 1,600 people with knee OA. The first phase found that a small subset of patients with moderate-to-severe arthritis experienced significant pain relief from combined glucosamine and Chondroitin. The 2008 phase found that glucosamine and Chondroitin, together or alone, did not slow joint damage. And in the two-year-long 2010 phase, glucosamine and Chondroitin were found as effective for knee OA as celecoxib (Celebrex). But a 2010 meta-analysis of 10 trials involving more than 3,000 patients published in BMJ found no benefit from Chondroitin, glucosamine or both. A separate 2011 study showed a significant improvement in pain and function in patients with hand OA using Chondroitin alone. Benefits of Chondroitin and glucosamine remain controversial, but the supplements appear extremely safe. 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 Glucosamine and Chondroitin 200 mg because some additive is also required in the formulation and the average weights are 2000 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 and Chondroitin is a special formulation that proves the pharmacological value to nourish the joint health. Glucosamine and Chondroitin 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 and Chondroitin 200 mg three times a day. But it’s very difficult to compress the tablet at huge weight 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. 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 are lubricated using suitable lubricants / Glidant / Antiadhrants were good in their flow properties. Assay and dissolution studies were conducted by the HPLC method.
Keywords: Stable glucosamine So4 KCL & Chondroitin tablets, solid formulation of glucosamine 1500 mg tablet, Force Feeder, Non Acqous binding.
[Full Text Article]
[Download Certificate]