Formulation and Development of Ketorolac Tromethmaine Ophthalmic Solution
- *Corresponding Author:
- Amit Bhople
Department of Drug Regulatory Affairs
BDA Pharma Pvt. Ltd., 83 Shivam, Ambazari Layout
Nagpur, Dist. Nagpur, Maharashtra, India
Tel: +91 902869629, + 91 9665061140
E-mail: [email protected]
Received Date: February 01, 2013; Accepted Date: March 08, 2013; Published Date: March 14, 2013
Citation: Bhople A, Deshpande S, Sheiakh S, Patange H, Chandewar A, et al. (2013) Formulation and Development of Ketorolac Tromethmaine Ophthalmic Solution. J Bioequiv Availab 5:099-109. doi: 10.4172/jbb.1000142
Copyright: © 2013 Bhople A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Ophthalmic preparations are specialized dosage forms designed to be instilled on to the external surface of eye (topical), administered inside (intraocular), adjacent to the eye (periocular) or used in conjunction with any special device. The preparation may have any several purposes like therapeutic, prophylactic or palliative. Ketorolac tromethmaine is a Nonsteroidal anti-inflammatory drug. It is used as Antipyretic, anti-inflammatory and analgesic. It is indicated Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Therefore, the aim of the present study was to formulate a formulation for ketorolac tromethmine (0.5%) ophthalmic solution using different concentration of Benzalkonium chloride as preservative. While reducing the concentration of Benzalkonium chloride it must be keep in mind that added quantity of preservative must meet compendial requirement of Preservative Efficacy Testing as per United State Pharmacopoeia (USP). The present research work is also planned to provide the data about the selection of suitable primary packaging material for Ketorolac tromethmine (0.5%) to achieve the better stability during the shelf life of the product. As there are several factors responsible for the incompatibility of packaging material with the product, most suitable packaging material must be selected. The product will be evaluated for stability, potency, toxicity, and safety under the accelerated conditions of temperature and humidity.