EVALUATION OF IN VITRO STABILITY STUDIES ON NUTRACEUTICALS IN ORAL SOLID DOSAGE FORMS WITH SPECIAL REFERENCE TO GLUCOSAMINE

Abstract

Pure Glucosamine is very hygroscopic and degrades (breaks down) rapidly when exposed to moisture or air. To avoid this, Glu cosamine needs to be bound to a stabilizer to be sold commercially. The sulfate and the HCL forms are two of th e most common agents that Glucosamine is bound to ensure its stability. After Glucosamine is bound, it is stable and will not degrade before it can get to the store shelf. Hence it is very difficul t to prepare Glucosamine base and instead find Glucosamin e Sulfate or Glucosamine HCL. Thus an attempt was made to stabilize the Glucosamine formulation by using the combination of a nti oxidant, Desiccant to resolve the problems associated with the Glucosamine formulati on . In the present formulation studies were carried for the stability studies as ICH guidelines with Real time and Accelerated stability studies and it was found to be stable during the study per iod of stability for three months. All the formulas with single desiccant and single ant - oxidant did not reduce the extent of the degradation. The tablets so prepared with conventional methods showed good results physical evaluation parameters and ch emical parameters such as Assay and Dissolution values. The granules prepared by using these ant oxidants and desiccant, were good in their flow properties. Glucosamine, an amino monosaccharides naturally occurring in the connective and cartilage tissues, contributes to mainta ining the strength, flexibility and elasticity of these tissues. Glucosamine is a precurs or to a molecule called a glycosaminoglycan, which is used in the formation and repair of cartilage. In recent years, glucosamine has been used widely to treat osteoarthr itis in humans and animal models. In vivo , glucosamine is typically converted to N - ace tyl - glucosamine. Non - steroidal anti - inflammatory drugs (NSAIDS) are effective in reducing inflammation but are not highly soluble and, in addition, may have undesirable side effects. Efforts have been made to improve the pharmac eutical properties of NSAIDs , such as permeability, solubility and stability, by creating NSAID prodrugs. Prodrugs are typically evaluated in relation to t he drug’s pharmacological and pharmacokinetic properties. These modifications may alter the physicochemical properties of the dru g, which may in turn effect the administration options that optimize drug delivery.