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Ophthalmic preparation, especially drops, is one of the common pharmaceutical dosage forms intended to be applied to the eye cavity for different pharmacological purposes. Sterility and freeing of microorganisms M.O. are considered one of the most important requirements of the ocular drops, so the manufacturers are very concerned about keeping the sterility of their products. As well as post-marketing pharmaceutical tests must be performed to verify that the eye drop meets the desired properties and withstand the storage condition in pharmacy and during the period after opening the container. The present study aimed to evaluate the preservation activity of different types of preservatives and concentrations utilized in selected eye drops marketed in Iraq Seven eye drops products were selected and purchased from the Iraqi pharmacies each product was cultured for four weeks at nutrient agar first, then if there is growth identified, the eye drop cultured in MacConkey and mannitol agar for determination of the type of MO. The addition of benzalkonium chloride (BK) in a concentration of 0.1 mg/mL as in both products (Apisulfa® by API and Orchadexoline® by Orchidia) can guarantee the product protection for 21 days and 14 days respectively. While the addition of benzalkonium chloride in concentration of 0.2 mg/mL does not protect dexamethasone® eye drop by Eipico. (Xolamol® by Jamjom pharma) results revealed that the 0.75 mg/mL of BK has different and variable protection levels between full to nil protection. Tymer® eye drop shows no growth at all samples cultured in the present study and from all patches in spite of the low concentration of BK. Some samples from apisulfa® and Dexamethasone® as the preservative agent lose their activity totally before 6 months of the expiration date (show M.O. growth at day zero). Tears natural® II by alcon contains (polidronium chloride) (PQ) in a concentration of 0.001%. Data obtained showed diverse results since samples from one patch show growth of M.O. since the first day while products from different patches show protection for three weeks. Samaphenicol® eye drop by SDI contains a mixed preservative (Thiomersal plus Poly quad (polidronium chloride)) in a concentrations of 0.005 and 0.001%, respectively. Results revealed that all samples survived without bacterial growth for three weeks and one out of three succeeded in staying sterile for the entire period of allowance. However, Staphylococcus aureus is only pathogen identified in the eye drops cultured. |
