Faculty of Pharmacy, Ziauddin Medical University, Karachi, Pakistan.
Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, Karachi, Pakistan.
Pak J Pharm Sci. 2020 Mar;33(2(Supplementary)):877-885.
The light sensitive pharmaceutical dosage forms are well protected from light by packing in light protective bottles especially the colored glass and plastic bottles. In the present study the transmission characteristics of transparent glass bottle, amber glass bottle, polyvinyl chloride amber plastic bottle (PVC) and low density polyethylene semi-opaque plastic bottles (LDPE) (empty and drug filled) have been evaluated and the data compared for compliance with Pharmacopoeial limits of percentage transmission. The variations in thickness affect the amount of light transmitted through the bottles. For an average thickness, the transmission of bottles was not uniform indicated the effect of manufacturing variables on the transmission of light. The drug filled bottles showed an increase in light transmission probably as a result of interaction between drug and bottle components. The leaching of any coloring agents from glass bottles or the pigments from plastic bottles into the solution during storage appeared to increase the transmission of light which could be detrimental to photosensitive drugs in a formulation. The light protective efficacy of bottles was in the order: Semi-opaque plastic (LDPE) > amber plastic (PVC) > amber glass. The photoprotection of aqueous solution of riboflavin as a model compound in these bottles has been studied and its shelf-lives and stability ratio were determined.
光敏感药物剂型通过包装在光保护瓶中（特别是有色玻璃和塑料瓶）来很好地避光。在本研究中，评估了透明玻璃瓶、琥珀色玻璃瓶、聚氯乙烯琥珀色塑料瓶（PVC）和低密度聚乙烯半透明塑料瓶（LDPE）（空瓶和装药物的瓶）的透光特性，并比较了数据是否符合药典规定的透光率百分比限制。厚度的变化会影响通过瓶子传输的光量。对于平均厚度，瓶子的透光率不均匀，表明制造变量对光传输的影响。装药物的瓶子的光透过率增加，可能是由于药物与瓶组件之间的相互作用。在储存过程中，任何着色剂从玻璃瓶中浸出或颜料从塑料瓶中浸出到溶液中，似乎会增加光的透过率，这可能对制剂中的光敏感药物有害。瓶子的光保护效果依次为：半透明塑料（LDPE）>琥珀色塑料（PVC）>琥珀色玻璃。研究了这些瓶子中核黄素水溶液作为模型化合物的光保护效果，并确定了其保质期和稳定性比。
