title: Evaluation of the stability of extemporaneously prepared ophthalmic formulation of mitomycin C.
abstract: Mitomycin C (MMC) is a cytostatic agent topically used in conjunctival neoplasms, secondary to glaucoma filtering, pterygium, and strabismus surgery to increase the success rate. The topical formulation of MMC for ocular use is always extemporaneously prepared. Our study evaluated the stability of extemporaneously prepared formulations of MMC at different concentrations (150, 300, & 600 microg/mL) kept at different temperatures (25 degrees , 4 degrees , and -70 degrees C) and at different pH range (6, 7, and 8). Aliquots from the above formulations were subjected for quantification of MMC on days 0, 7, 14, 21, and 28 using high-performance liquid chromatography. MMC stored at 25 degrees C for 6 months was also subjected to flow cytometry and compared to freshly prepared MMC. The results indicated that the degradation of MMC is very high in acidic pH at room temperature. Increasing the pH to 7 or 8 and keeping MMC at low temperatures significantly decreased the degradation of MMC. Interestingly, the flow cytometry data revealed that the 6-month-old MMC showed an antiproliferative effect compared to that of freshly prepared MMC. To conclude, the extemporaneously prepared MMC at pH between 7 and 8 and stored in the refrigerator can increase the duration of its stability. However, the antiproliferative study using flow cytometry revealed that degraded MMC retained its activity even after degradation.
authors.affiliation: Ocular Pharmacology Division, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. tvepandian@hotmail.com
authors.forename: Thirumurthy
authors.initials: T
authors.lastname: Velpandian
authors.forename: Vinay
authors.initials: V
authors.lastname: Saluja
authors.forename: Alok Kumar
authors.initials: AK
authors.lastname: Ravi
authors.forename: Srinivasan Senthil
authors.initials: SS
authors.lastname: Kumari
authors.forename: Rajani
authors.initials: R
authors.lastname: Mathur
authors.forename: Nihar
authors.initials: N
authors.lastname: Ranjan
authors.forename: Supriyo
authors.initials: S
authors.lastname: Ghose
mesh_terms: D000903:Antibiotics, Antineoplastic / Q000737:chemistry* / Q000494:pharmacology; D045744:Cell Line, Tumor; D049109:Cell Proliferation / Q000187:drug effects; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding / Q000592:standards; D004355:Drug Stability; D004356:Drug Storage; D005434:Flow Cytometry; D006801:Humans; D006863:Hydrogen-Ion Concentration; D016685:Mitomycin / Q000737:chemistry* / Q000494:pharmacology; D009883:Ophthalmic Solutions
chemical_list: D000903:Antibiotics, Antineoplastic; D009883:Ophthalmic Solutions; D016685:Mitomycin