Pharmacognosy, Phytochemistry & Natural Products

Biography

Biography: Kirankumar Hullatti

Abstract

Abstract

Quality by Design (QbD) concept is a systematic approach towards development of product that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Recent pharmaceutical regulatory documents have stressed the critical importance of applying QbD principles for in-depth process understanding to ensure that product quality is built in from the onset of manufacturing process. The use of Herbal medicines is on rise all over the world due to their promising therapeutic effects and fewer adverse effects. This has led to phenomenal increase in the demand for herbal medicines in the last two decades. The manufacturing process for the herbal drug products is complex and involves many unit operations. It is therefore significant to develop manufacturing process under the framework of QbD, which aims to build the quality of herbal drug product from the onset of its manufacturing process.

The concept has been widely accepted and applied in the pharmaceutical manufacturing industry. There are still issues that need to be addressed in the implementation of QbD for Herbal drugs. Some of these issues discussed in the lecture are, variation in the quality of herbal raw material and identification of the correct source and such as extraction and suitable formulation, defining the critical quality attributes during development of herbal drug product. Therefore this presentation aims to give an brief information regarding the application of QbD principle to improve the process development and formulation of herbal drug product.

Recent Publications

1. Mahesh Biradi and Kirankumar Hullatti, (2017) Bioactivity guided isolation of cytotoxic terpenoids and steroids from Premna serratifolia, Pharmaceutical Biology, Vol. 55, No. 1, 1375–1379
2. Kirankumar Hullatti, Analee Rodrigues, Vinod Mannur, Vinayak Mastiholimath, and Vijay Kumar Rasal,(2016) Chemical Fingerprinting and Quantification of Biomarker Wedelolactone in Different Sources of “Bhringaraja” by High-Performance Thin-Layer Chromatography and Method Validation, Journal of Planar Chromatography, 29 (5), 330–335
3. Telagari M. and Hullatti K. K., (2016) In Vitro Screening of Actiniopteris dichotoma For Enzyme Inhibitory Activity Related To Type 2 Diabetes, Indian Drugs, 53(06), 70-73
4. Madhusudhan Telagari, Kirankumar Hullatti, In‑vitro α‑amylase and α‑glucosidase inhibitory activity of Adiantum caudatum Linn. and Celosia argentea Linn. extracts and fractions., Indian J Pharmacol 2015;47:425-9.
5. Anil Kumar Raju Banappa S. Unger, Kirankumar Hullatti and Madhusudhan Telagari. Evaluation of anti asthmatic activity of hydro alcoholic extract of Citrullus colocynths and Cucumis trigonus fruits. J App Pharm Sci, 2015; 5 (08): 126-130.