FORMULATION AND EVALUATION OF TAFLUPROST OPHTHALMIC SOLUTION
The aim of the present study was to formulate, develop and evaluate ophthalmic solution containing Tafluprost. The selected prostaglandin analogue belongs to BCS - II. So to increase the solubility of the Tafluprost in WFI Beta Cyclodextrin was used by performing various trials variables of the experiments procedure Stirring time and speed were optimized to enhance the solubility. From the experimental procedure with different trails 20mg/mL of Cyclodextrins was fixed for the optimized formula. The product were characterized for appearance, physical state, colour and odour of the drug characteristics. The prepared formulations were evaluated for pH, osmolality and assay and found to be in acceptable ranges. Stability study was carried out for optimized formulation at 40°C±2°C /NMT 25%RH and 30°C ±2°C/ 65%±5% RH for 3 months, were evaluated for pH ,osmolality ,assay found to be within acceptable limits. Finally it can be concluded that the in house product Tafluprost ophthalmic solution was met with in the specification.
2. Hiroyoshi Kasai, Yumiko Aoyama, Takashi Kurasawa,et al. Comparison of Efficacy and Safety Evaluation of Tafluprost Formulations with and without Preservative, Pharmacology & Pharmacy, 2013; 4:377-384.
3. Toxicological evaluation of preservative-containing and preservative-free topical prostaglandin analogues on a three-dimensional-reconstituted corneal epithelium system, Br J Ophthalmology 2011; 95:869e875.
4. Kumar Lokesh, Rathee Permender and Kumar Vikash, Role of Prostaglandins in Glaucoma: Design and Optimization, International Journal of Clinical Toxicology, 2015; 3:18-28.
5. Raber S, Courtney R, Maeda-Chubachi T, et al Tafluprostsystemic exposure in pediatric and adult patients with glaucoma: a phase 1, open-label study. Ophthalmology. 2011; 118:2022–2027.
6. Pasupathi A, Srinivas Reddy A, Margret Chandira R, et al. Preparation, Characterization and Evaluation of Aqueous Eye Drops of Prostaglandin Analogues, The Pharma Research (T. Ph. Res.), 2010; 4:51-60.
7. Perkins ES. Prostaglandins and the eye. Adv Ophthalmol. 1975; 29:2–21.
8. Bito LZ, Stjernschantz J, Resul B, Miranda OC, Basu S. The ocular effects of prostaglandins and the therapeutic potential of a new PGF2 alpha analog, Tafluprostfor glaucoma management. J Lipid Mediat. 1993; 6:535–543.
9. Camras CB, Alm A. Initial clinical studies with prostaglandins and their analogues. Surv Ophthalmol. 1997; 41 Suppl 2:S61–S68.
10. Stefano Ranno, Matteo Sacchi, Cinzia Brancato,et al. A Prospective Study Evaluating IOP Changes after Switching froma Therapy with Prostaglandin Eye Drops Containing Preservatives to Nonpreserved Drug y in Glaucoma Patients, The Scientific World Journal Volume 2012.
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