Preparation and Characterization of Novel Co-Crystal Forms of Domperidone

P. Mounika¹*, G. Divya¹, S. Vijaya Raj¹, A. Gowramma^2
1Department of Pharmaceutical Analysis, Sree Vidyanikethan College of Pharmacy, A.Rangampet, Tirupati, A.P, India.
²Department of pharmaceutics, Sri Padmavathi School of Pharmacy, Tiruchanoor, Tirupati, Andhra Pradesh, India.

A B S T R A C T
Domperidone is a widely used antiemetic, poorly water soluble drug, erratically absorbed in stomach and possess several dissolution-related problems. The co-crystal formation by supramolecular approach has proven to be advantageous over the various methods of improving solubility due to its simple mode of preparation, where the stability as well as the solubility of the drug is improved. The co-crystals of Domperidone were prepared using Succinic acid as a co-former (1:1, 1:2 & 1:3) by cooling crystallization technique and characterized by IR, DSC, SEM and XRD studies. The in vitro dissolution studies were also performed. In distilled water, the solubility of domperidone in the Co crystal 1, 2, and 3 has shown increase in solubility compared to pure drug by 43.84, 47.54, and 52.3 folds respectively. In pH 1.2 HCl buffer solution, the solubility of domperidone in Cocrystals 1, 2 and 3 has shown increase in solubility compared to pure drug by 1.18, 1.10 and 1.05 folds respectively. Drug content of domperidone cocrystals 1, 2 and 3 was found to be 95.13%, 93.47% and 85.44% respectively. Percentage practical yield of domperidone cocrystals 1, 2 and 3 was found to be 74.21%, 60.51% and 56.48% respectively. The in-vitro dissolution studies, when compared to the formulation of Domperidone the prepared cocrystal-3(1:3) has shown maximum drug release of 89.45% with water and cocrystal-1(1:1) has shown maximum drug release of 87.76% with 0.01 N HCL as a dissolution medium.                             
Keywords: Co-Crystal, Domperidone, Succinic acid, supramolecular approach