Ophthalmic solutions sterile

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

Solutions for external or oral use do not require sterilization but generally contain antimicrobial preservatives. Ophthalmic solutions and parenteral solutions require sterilization (qv). 

Because of these product sensitivities, most ophthalmic pharmaceutical products are aseptically manufactured and filled into previously sterilized containers in aseptic environments using aseptic filling-and-capping techniques. This is the case for ophthalmic solutions, suspensions, and ointments, and specialized technology is involved in their manufacture. 

In general, aqueous ophthalmic solutions are manufactured by methods that call for the dissolution of the active ingredient and all or a portion of the excipients into all or a portion of the water and the sterilization of this solution by heat or by sterilizing filtration through sterile depth or membrane filter media into a sterile receptacle. If incomplete at this point, this sterile solution is then mixed with the additional required sterile components, such as previously sterilized solutions of viscosity-imparting agents, preservatives, and so on, and the batch is brought to final volume with additional sterile water. 

Ophthalmic ointments and solutions Sterility test, CCI, AET Test all batches on stability with the exception of the first three batches for AE 0, 12, 24, 36 months... 

Topical dosage forms such as unpressurized sprays, lotions, ointments, solutions, and suspensions may be considered for marketing in glass bottles with appropriate dispenser. Some topical drug products, especially ophthalmic, are sterile or may be subject to microbial limits. In these cases, packaging material and handling should be done as those for injectables. 

Highest High Inhalation aerosols and solutions injection injectable suspensions Ophthalmic solutions and suspensions transdermal ointments and patches nasal aerosols and sprays Sterile powders and powders for injections and inhalation powders ... 

Levobunolol is suppUed as a 0.25% and 0.5% sterile ophthalmic solution of the levo-isomer of the hydrochloride salt.The formulation contains a viscosity agent, 1.4% polyvinyl alcohol, and is preserved with BAG 0.004% (see Table 10-1). 

Metipranolol is available in the United States as OptiPranolol, a sterile ophthalmic solution of 0.3% racemic metipranolol HCl preserved with 0.004% BAG and approved for twice-daily use. 

Naido NT, Price CH, McCarthy TJ. Preservative loss from ophthalmic solutions during filtration sterilization. Aust Pharm Sci 1972 1(1) 16-18. 

BImatoprost. Bimatoprost (Lumigan) is supplied as a sterile 0.03% ophthalmic solution in 2.5- and S.O-mL sizes. The recommended dosage of bimatoprost is limited to one drop into the affected eye once daily in the evening. Increased use may decrease its beneftcial effect. If used concurrently with other lOP-lowering drugs, a waiting period of S minutes should separate administrations. 

Latanoprost Latanoprost (Xalatan) is available as a 0.005% sterile ophthalmic solution in a 2.S-mL dispenser bottle. Latanoprost is also marketed as a combination ophthalmic product with the /3-adrenergic blocking agent timolol, which apparently enhances lOP-lowering by decreasing the production of aqueous humor. Cautions and side effects are similar to those for other ophthalmic prostanoids. 

Travoprost. Travoprost (Travatan) is supplied as u 2.5-mL sterile 0.(X)4% ophthalmic solution in a 3.5-mL ran-tainer. Travoprost is claimed to be the most potent and FP-specific analogue in this product category. Cautions and side effects are similar to tho.se given above. 

Unoprostone. Unoprostone (Rc.scula) is supplied as a 0.15% sterile ophthalmic solution. Unoprostone Is somewhat unusual, in that it is a docosanoid (22-carbon atom) PGF.<. analogue marketed as the isopropyl ester. The natural 1. -position alcohol is oxidized to the ketone, as would be ci. pected to occur in vivo. Cautions and side eflecis are similar to those given above. 

The pH is the most important factor in the stability of sulfacetamide sodium solutions. Among the 20% ophthalmic solutions of the drug, the greatest stability (to two years) is shown by the solutions with a pH of 8-8.5 (112). The addition of 200mg/100 ml of sulfacetamide to 30% ophthalmic solutions of sulfacetamide sodium decreases the pH from 9.3-9.6 to 7.3-8.4 and increases the shelf life of the solution after sterilization at 100°C for 30 minutes to more than one year (113). 

It is noteworthy that, at least presently, sterilization is not required for all drugs. It depends on the type of administration. Hence, it concerns mostly ophthalmic preparations, sterile topical products and injectable solutions, including intramuscular, intravenous and sub-cutaneous ways. 

Finally, a microbiological technical data section is necessary for any NDA for which a sterile claim is being made—this would include such products as large and small volume parenterals and sterile ophthalmic solutions. 

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