title: Ophthalmic delivery of ciprofloxacin hydrochloride from different polymer formulations: in vitro and in vivo studies.
abstract: Reservoir-type ocular inserts were fabricated using sodium alginate containing ciprofloxacin hydrochloride as the core (drug reservoir) that was sandwiched between the Eudragit and/or polyvinylacetate films. Ocular inserts were packaged in aluminium foil and sterilized by gamma radiation. These were tested for sterility as per British Pharmacopoeia (BP). Ocular inserts were evaluated for in vitro release rate studies, microbial efficacy, in vivo release studies, efficacy against induced bacterial conjunctivitis in rabbit's eyes, concentration in the aqueous humor, and stability studies as per the International Conference on Harmonization (ICH) guidelines. Ocular inserts passed the test for sterility. They showed zero-order release of the drug in the in vitro and in vivo release studies over a period of 120 hr. The drug was found to be active against selected microorganisms as was proved by microbial efficacy studies. A high correlation coefficient was found between in vitro and in vivo release rate studies. Better improvement was observed in artificially induced bacterial conjunctivitis in rabbit's eyes, compared with marketed eye drops and placebo. Drug concentration in the aqueous humor was found above Minimum Inhibitory Concentration (MIC-90) against selected microorganisms. Shelf-life of the product was found to be more than 2 years.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi, India. naseem102@yahoo.com
authors.forename: Naseem A
authors.initials: NA
authors.lastname: Charoo
authors.forename: Kanchan
authors.initials: K
authors.lastname: Kohli
authors.forename: Asgar
authors.initials: A
authors.lastname: Ali
authors.forename: Areeg
authors.initials: A
authors.lastname: Anwer
mesh_terms: D000287:Administration, Topical; D000818:Animals; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D001082:Aqueous Humor / Q000378:metabolism; D002626:Chemistry, Pharmaceutical; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D015169:Colony Count, Microbial; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy / Q000382:microbiology; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D004343:Drug Implants; D004355:Drug Stability; D004926:Escherichia coli; D066298:In Vitro Techniques; D011108:Polymers; D011817:Rabbits; D013211:Staphylococcus aureus / Q000187:drug effects; D013678:Technology, Pharmaceutical; D013997:Time Factors
chemical_list: D000890:Anti-Infective Agents; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D004343:Drug Implants; D011108:Polymers; D002939:Ciprofloxacin