Abstract

VITAMIN D3 -EXCIPIENT COMPATIBILITY STUDIES FOR ORODISPERSIBLE TABLETS NOVEL DRUG DELIVERY SYSTEMS DEVELOPMENT

Mahmoud Mahyoob Alburyhi*, Mokhtar Abd-hafiz Al-Ghorafi, Abdalwali Ahmed Saif, Maged Alwan Noman and Sami Ahmed Saeed

ABSTRACT

Vitamin D3 (Cholecalciferol) is a form of Vitamin D used in the treatment of specific medical conditions such as refractory rickets, hypoparathyroidism, and familial hypophosphatemia, as well as osteoporosis and chronic kidney disease. The main objective of the present study was to the preformulation studies were performed to know the physico-chemical and mechanical properties of Vitamin D3 (Cholecalciferol) for formulation development of ODTs. The drug-excipient compatibility studies were conducted to characterize the drug Vitamin D3 present in Orodispersible tablets (ODTs). The safety, efficacy, quality and stability of a formulation are major concepts of any API development process. In API development process, a detailed characterization of the API and other formulation components is usually carried out during the preformulation stage. Preformulation, formulation and evaluation of Vitamin D3 to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and bioavailability and also to improve bioavailability and Vitamin D3 is an essential nutrient that plays a crucial role in calcium homeostasis, bone health, and immune function. In the present study that the compatibility was assessed by, FTIR spectroscopy, and melting point apparatus, precompression parameters and powder flow properties. Results showed that physical mixtures of Vitamin D3 and various excipients as lactose monohydrate, mannitol, microcrystalline cellulose as diluents, and sodium starch glycolate, croscarmellose sodium, and crospovidone as superdisintegrants agents were evaluated for preformulation studies parameters. It was concluded that the drug Vitamin D3 was found to be compatible with various excipients which were selected for the formulation development of the Vitamin D3 ODTs NDDS. Formulation scientist from his experience and knowledge have to significantly in the preformulation study stage and is an important factor in the NDDS (Novel Drug Delivery Systems) product development process.

Keywords: Vitamin D3 (Cholecalciferol), Bone Health, Compatibility, Excipients, Development, Preformulation, Novel Drug Delivery Systems.