Extemporaneous Preparation of 20 mg/mL Ganciclovir in Artificial Tears in Comparison with Sterile Water for Ophthalmic Administration: Formulation and Stability Study

被引：1

作者：

Leanpolchareanchai, Jiraporn ^{[1
]}

Tangteerakoon, Patamaporn ^{[2
]}

Supapsophon, Patcharin ^{[3
]}

Sukavatcharin, Somsiri ^{[4
]}

Simaroj, Pornchai ^{[4
]}

Suksiriworapong, Jiraphong ^{[1
]}

机构：

[1] Mahidol Univ, Fac Pharm, Dept Pharm, Bangkok 10400, Thailand

[2] Ramathibodi Hosp, Fac Med, Pharm Dept, Chemotherapy Pharm Unit, Bangkok 10400, Thailand

[3] Ramathibodi Hosp, Fac Med, Somdech Phra Debaratana Med Ctr, Pharm Serv, Bangkok 10400, Thailand

[4] Mahidol Univ, Ramathibodi Hosp, Fac Med, Dept Ophthalmol, Bangkok 10400, Thailand

来源：

PHARMACEUTICS | 2023年 / 15卷 / 01期

关键词：

ganciclovir; extemporaneous preparation; eye drop; stability; artificial tear; TOPICAL GANCICLOVIR; CLINICAL-FEATURES; CYTOMEGALOVIRUS; 0.15-PERCENT; OSMOLARITY; THERAPY; GEL; PH;

D O I：

10.3390/pharmaceutics15010208

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Ganciclovir is available as a lyophilized powder for reconstitution and is normally used to treat ophthalmic viral infections. The use of ganciclovir in artificial tears containing hydrocolloid polymers may prove beneficial to patients during drug application, by prolonging contact time and providing a moistening effect. Therefore, this study aimed to extemporaneously prepare 20 mg/mL ganciclovir in artificial tears and compare its stability with that of a similar concentration of ganciclovir in sterile water (SWI) for ophthalmic administration. First, a compatibility study of the drug with commercial artificial tears found that it was compatible with artificial tears containing sodium hyaluronate (HYA). Subsequently, ganciclovir/0.1% HYA (HYA0.1) and ganciclovir/SWI eyedrops (EDs) in low-density polyethylene (LDPE) eyedrop bottles packed in light-shielded zipper bags were evaluated for their stability at 5 +/- 3 degrees C and 30 +/- 2 degrees C. The results revealed that ganciclovir/SWI ED had good physicochemical and microbiological stability when stored at 5 +/- 3 degrees C for 12 weeks and at 30 +/- 2 degrees C for 8 weeks. Meanwhile, ganciclovir/HYA0.1 ED was stable for 8 weeks when kept at 5 +/- 3 degrees C and at 30 +/- 2 degrees C, but ganciclovir in 0.3% HYA ED could be stored at 5 +/- 3 degrees C for 8 weeks. Nevertheless, particulate matter may need to be investigated using a suitable method to ensure the absence of invisible particles in these preparations. Of these results, ganciclovir/HYA artificial tears and SWI EDs show potential for use as home medications for the treatment of ophthalmic viral infections.

引用

页数：17