A REVIEW ON FORMULATION DEVELOPMENT AND INVITRO EVALUATION OF MOUTH DISSOLVING TABLET OF PIOGLITAZONE HYDROCHLORIDES

Kausar Shafaat*, Rakesh Kumar Sahu, Abhishek Kumar, Roushan Kumar, Abinash Kumar Mishra, Sonu Kumar, Sandeep Kumar, Pratik Kumar

Mouth Dissolving Tablets (MDTs) have emerged as a cornerstone in patient-centric drug delivery systems, particularly for the management of chronic metabolic disorders such as Type 2 Diabetes Mellitus. Pioglitazone Hydrochloride, a potent thiazolidinedione, serves as the primary therapeutic agent in this context; however, its clinical utility is often hampered by its classification as a BCS Class II drug. This classification highlights the drug’s inherent challenges: low aqueous solubility and a dissolution-rate-limited absorption profile. This review article provides an exhaustive analysis of the formulation development of Pioglitazone MDTs, emphasizing the transition from conventional oral solids to rapid-disintegrating matrices that bypass the need for water, thereby facilitating immediate drug initiation and improving adherence among geriatric patients suffering from dysphagia. The formulation landscape is meticulously examined, focusing on the synergistic use of superdisintegrants such as Crospovidone, Croscarmellose Sodium, and Sodium Starch Glycolate. We delve into the molecular mechanisms of disintegration—specifically wicking, swelling, and strain recovery and how these forces are optimized to achieve a disintegration time of less than 60 seconds. Furthermore, the review explores advanced solubility enhancement strategies, including solid dispersions, inclusion complexation with beta-cyclodextrins, and the utilization of pore-forming agents via the sublimation technique. These methods are critical for ensuring that once the tablet disintegrates, the Pioglitazone particles are in a state that favors rapid transition into the systemic circulation.