Design Fabrication and Validation of Fixed Combination for Anti Glaucoma Ophthalmic Drugs

Abstract

For this study we were assessed physiochemical properties like description, solubility, identification and assay of Brimonidine tartrate, Timolol maleate and Dorzolamide HCl. Identification test results by FTIR and HPLC were helpful to assess compatibility of the material with drug formulation in qualitatively good. Assay or purity test results were showed that the drug formulation with safe and effective. Compatibility study of drug product with product contact material was performed. Based on the results obtained it could concluded that BTD drug product was found compatible with platinum cured silicone tubes, metal SS316L, Nylon membrane filters and Plastic containers. The materials and methods used in this study proved that the drug was not have any physical and chemical incompatibilities and found to be stable. Stability study results also revealed that the BTD formulation was stable upto the declared shelf life of the product. Process validation and method validation parameters results ensured that the process and method was consistent to produce quality of product. Microbiological evaluation like Bioburden and Endotoxin revealed that the BTD drug compatible to the patient to be used safely. The data obtained in present study will be helpful in the formulation of anti-glaucoma drugs in fixed dose combination. From the above data it is clear that there is no incompatibility with three combinational drugs with excipients. So the drugs are combined and formulated as fixed dose combination and safely to use in ophthalmic field. This study focused on the efficacy and safety profile of fixed combination of Brimonidine tartrate 0.2% timolol maleate 0.5% and dorzolamide 1% ophthalmic solution for the treatment of glaucoma and ocular hypertension (OH). This preparation is likely to have a valuable role in the therapeutic management of Glaucoma. It is substantially more affordable than other therapy and has less potential to cause systemic adverse effects. In human clinical use, chance of any adverse effects will be insignificant.