Abstract
Co-crystals is a multi-component system which connected by non-covalent interactions, present physically as a solid form under ambient conditions. Nowadays, co-crystal has becoming as an alternative approach to improve the bioavailability of poor water soluble drugs especially for a weakly ionisable groups or neutral compounds. In this study the co-crystal screening was carried out for carbamazepine (CBZ) and fumaric acid (FUM) co-crystal former (CCF) using non-stoichiometric method (addition of CBZ to CCF saturated solution) and stoichiometric method (evaporation of 1:1 molar ratio of CBZ to CCF) in acetonitrile, ethyl acetate, propanol, ethanol and formic acid solvent systems. The crystals produced from the screening were characterized using Powder X-ray Diffraction (PXRD), Differential Scanning Calorimetry (DSC) and Fourier Transform Infrared (FT-IR). The PXRD analysis had confirmed that the co-crystal was successfully formed in both methods for all of the solvent system studied with an exception to formic acid in the stoichiometric method where no crystal was found precipitate. The findings from this study revealed that Form A and Form B of CBZ-FUM co-crystal had been successfully formed from different solvent systems.
Highlights
Developers and regulatory authorities in pharmaceutical industry are favouring the pharmaceutical crystal because it provides high purity products that are superior with regard to scalability and reproducibility [1]
The aim of this study is to investigate the CBZ-fumaric acid (FUM) co-crystal formation using non-stoichiometric method which including continuous shaking and stirring and stoichiometric method of solvent evaporation in five different solvent systems
Powder X-ray diffraction (PXRD) had been used to identify the presence of cocrystal since every crystalline solid phase has its unique PXRD pattern [24]
Summary
Developers and regulatory authorities in pharmaceutical industry are favouring the pharmaceutical crystal because it provides high purity products that are superior with regard to scalability and reproducibility [1]. The pharmaceutical industry deeply wanted to meet patient’s therapeutically needs with the invention of cocrystal where the active pharmaceutical ingredient (API) and co-crystal former (CCF) are playing a key role in formulation development of co-crystal [2]. Co-crystals are considering as a major class of pharmaceutical materials to promote the solubility and dissolution. Apart from co-crystals, other materials such as polymorphs, salts, and amorphous solids are widely used to enhance dissolution and bioavailability of less soluble API [7], [8]. The enhancement of drug solubility is required in the pharmaceutical industry [9] and solubility is known as the key factors in determining the efficacy as well as the activity of a drug. The aim of this study is to investigate the CBZ-FUM co-crystal formation using non-stoichiometric method which including continuous shaking and stirring and stoichiometric method of solvent evaporation in five different solvent systems (acetonitrile, ethyl acetate, propanol, ethanol and formic acid)
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