- Lincomycin Hydrochloride for Intramuscular (I.M) and Intravenous (I.V) (300 mg / ml w/v) Injection تصييغ تركيبة لنكومايسين هايدروكلورايد (300 mg / ml w/v) للحقن العضلي والوريدي

Abstract

Lincomycin injection is a sterile solution contains lincomycin hydrochloride which is the monohydrate salt ,used to reduce the development of drug resistant bacteria and to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. The aim of present study was to prepare and evaluate a pharmaceutical formula of lincomycin HCl 300 mg /ml (w/v) injection for Intravenous (I.V) or Intramusular (I,M) administration . Different formulas were carried out in order to maintain the most stable formula that will be applicable according to pharmaceutical requirement . Easy solubilization of lincomycin HCl in water allowed to obtain the final formulation by few and simple steps. Benzyl alcohol was used as a preservative and analgesic , no antioxidant , no buffering agent were employed . Beause lincomycin HCL solution has been shown to have isotonicity properties , no isotonic agent was used .The sterilization was carried out by filtration system through (0.02 µm). membrane filter. The stability study was carried out on optimized formula according to International Conferene Harmonization (ICH) Guidelines. The result of stability study was indicated , that the proposed formula was stable and no any major changes were observed in physico-chemical properties .