Zeitschrift für Bioäquivalenz und Bioverfügbarkeit

Abstrakt

Formulation and Development of Ketorolac Tromethmaine Ophthalmic Solution

Amit Bhople, Santosh Deshpande, Sameer Sheiakh, Harish Patange, Anil Chandewar and Suyog Patil

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.