Department of RIC, IKG Punjab Technical University, Kapurthala, India
Department of Pharmaceutics, Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial College of Pharmacy, Bela, Ropar, Punjab, India
Overseas R & D Centre, Overseas Health Care Pvt Ltd., Phillaur, Punjab, India
Correspondence: Verma H, Overseas R & D Centre, Overseas Health Care Pvt Ltd., Phillaur, Punjab, India.
Garg R., Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial College of Pharmacy, Bela, Ropar, Punjab, India
Biopharmaceutics Classification System (BCS) provides a basis on which regulatory authorities can give wavier to unnecessary human trials by considering the fundamental properties of drug molecule viz. solubility and permeability. Present research aims to classify magnesium orotate (MOD) into its appropriate BCS class so as to guide pharmaceutical scientists to develop better formulations to ensure its good bioavailability. Equilibrium solubility and dynamic dissolution studies of MOD were conducted in different physiological media and dose solubility ratio was calculated with respect to both therapeutic dose (1000 mg equivalent to 65.6 mg elemental magnesium) as well as the highest available strength (500 mg equivalent to 32.8 mg elemental magnesium). Permeability of MOD was assessed using the noneverted rat intestinal sac model to find out the percent absorption of MOD when taken orally as a single dose. These results were further verified by conducting a single-dose pharmacokinetic study in Wistar rats. Based on equilibrium solubility and dynamic dissolution studies, at a dose of 500 mg, magnesium orotate was found to comply with the high solubility criterion of BCS, but it was not the case with 1000 mg dose. MOD had good permeability and absorption as more than 90% of tested dose permeated the intestinal mucosa and recovered in urine. Hence, quantitatively at a dose of 500 mg MOD belongs to class I and at a dose of 1000 mg it belongs to class II of BCS.