Abstract

DICLOFENAC-EXCIPIENT COMPATIBILITY STUDIES FOR ADVANCED DRUG DELIVERY SYSTEMS DEVELOPMENT

Mahmoud Mahyoob Alburyhi*, Maged Alwan Noman, Abdalwali Ahmed Saif, Mokhtar Abd-hafiz Al-Ghorafi, Tawfeek A. A. Yahya, Shada Hassan Yassin and Mohammed A. Al Khawlani

Abstract

Diclofenac is a non-steroidal anti-inflammatory drug used to treat mild to moderate pain and inflammation. It is commonly prescribed to treat various types of arthritis and pain or inflammation post-surgery. Diclofenac is poorly water soluble and the mean drug half-life in plasma is approximately 2 hours after oral doses. Preformulation is essentials of pharmaceutical science that utilizes biopharmaceutical principles in the determination of physicochemical properties of the drug substance. Prior to the development of any dosage form new drug, it is essential that certain fundamental physical and chemical properties of drug powder are determined. This information may dictate many of subsequent event and approaches in formulation development. The aim of the present study was to the preformulation studies were performed to know the physicochemical and mechanical properties of Diclofenac for Orodispersible tablets ODTs. The drug-excipient compatibility studies were conducted to characterize the drug Diclofenac present in Orodispersible tablets Drug Delivery System ODDs. Preformulation, formulation and evaluate of Diclofenac to avoid problems associated with conventional delivery system such as limited permeation, low dissolution and also to improve bioavailability and to treat various types of pain or inflammation. In the present study that the compatibility was assessed by, FTIR spectroscopy, and melting point apparatus. Results showed that physical mixtures of Diclofenac and various excipients such as mannitol, microcrystalline cellulose, lactose anhydrous, pregelatinized starch, as diluents, and sodium starch glycolate, croscarmellose sodium, and crospovidone as superdisintegrants and citric acid anhydrous, HPMC were investigated by FTIR it was detected that there was no variation or minor deviation in the characteristic peaks in FTIR spectroscopy. The Diclofenac formulations precompression were evaluated which were found to be within limits. It was concluded that the drug Diclofenac was found to be compatible with various excipients which were selected for the formulation development of the Diclofenac ODTs. Formulation scientist from his experience and knowledge have to significantly in the preformulation study and is an important factor in the ADDS product development process.

Keywords: Diclofenac, Compatibility, Excipients, Development, Preformulation, Formulation.