Monday , 6 February 2023

Design, Characterization and Evaluation of Chrono-modulated Nateglinide using pulsatile Drug Delivery System

Angilicam Avinash*, Avula Sushma, Koneti Lalasa, Siddabathina Prasanth Kumar, Thumati Gowthami, Dr. M. Sreenivasulu
Narayana Pharmacy College, Chinthareddypalem, Nellore, Andhra Pradesh, India-524003.

In present study pulsatile drug delivery system of nateglinide was developed to control early morning hyperglycemia to synchronize the circadian rhythm of diabetes mellitus. Nateglinide is a novel anti diabetic drug that lowers blood glucose levels by stimulating insulin secretion from the pancreas. One of the major problems with this drug is its low solubility in biological fluids, which results into poor bioavailability after oral administration. The solubility of nateglinide was enhanced by using in situ micronization technique by using hydrophilic stabilizers like PVP K30, Hupu gum. The formed micro-crystals were evaluated for %practical yield, drug content, % drug release, FT-IR, DSC, XRD, and SEM. The optimized micro-crystals (F5) were selected as the best formulation for the development of pulsincap. Pulsincaps were formulated using body of the capsules treated with formaldehyde to modify its solubility and polymer plug of HPMC, Xanthan gum, lactose, gelatine was fitted in mouth of the capsule body. In vitro release study were carried out using pH 1.2 buffer for a period of 2 h then 6.8 pH phosphate buffer for a period of 6 hours. Batch P1 containing HPMC as a plug shows required lag time of 6 hours that release drug in the early morning hours.
Keywords: In situ micronization technique, Nateglinide, Pulsincap, Solubility.

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