Development of oil based vitamin compositions in stable soft capsule form

One of the applications of oral preparation is the soft capsule dosage form in the pharmaceutical industry. Although the soft capsule form has existed in the pharmaceutical industry for a long time, its frequency in practice is just increasing. Especially its application in oil based vitamin containing preparations provides an advantage in terms of functionality. The aim of the study is to develop the formulation and production method of vitamin D, an oil-based vitamin, as a drug or food supplement, and to optimize and evaluate the methods required for this in terms of quality parameters, stability monitoring and other analytical studies. Vitamins are not stable due to exposure to light, heat and air. Therefore, they cannot provide stability throughout the shelf life of the product after it is produced. Various antioxidant aids are used to improve stability. Therefore, an easy, repeatable process and formulation has been developed as an alternative. In this study, stable vitamin D compositions in soft capsule form were obtained by determining the appropriate medium chain triglyceride by applying a nitrogen process and under a sodium lamp, without containing antioxidants. Two different compositions of vitamin D, sunflower oil and myritol, were compared. In this way, the process step was shortened and time was saved. In addition, optimizations were made for analytical method studies and quantification and analysis of related substances were carried out. In this way, stability monitoring was carried out in comparative products.