Complex generics: Understanding and optimizing the performance of Oral Solid Dose (OSD) Drug Products

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00:00:00 Welcome
00:00:13 Introduction
00:01:03 Complex generics: Understanding and optimising the performance of Oral Solid Dose Drug ProductsApplication of physicochemical characterisation methods in OSD product development
00:02:25 Complex generics: Understanding and optimising the performance of Oral Solid Dose Drug ProductsApplication of physicochemical characterisation methods in OSD product development
00:03:47 Proposed OSD deformulation workflow
00:07:28 Critical material properties for OSD
00:08:40 Possible development timeframe
00:10:33 Complex Generic Products
00:12:12 The FDA sets different equivalence requirements dependant on the RLD product complexity
00:13:54 Malvern PANalytical measurement solutions
00:15:17 Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data
00:16:32 Morphologically Directed Raman Spectroscopy can provide particle size, shape and chemical ID data
00:16:57 MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:17:15 MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:17:33 MDRS measures component specific size and shape distributions in support of deformulation and IVBE studies
00:18:03 Oral solid dose: deformulation and IVBE
00:19:44 Bioavailability relates to particle size and solid form
00:22:04 Complex product deformulation using MDRS
00:23:05 Complex product deformulation using MDRS
00:24:04 Complex product deformulation using MDRS
00:24:53 Detecting the presence of different API polymorphs
00:25:59 Linking dissolution rate to particle shape measurements
00:26:29 Linking dissolution rate to particle shape measurements
00:27:39 Understanding the manufacturing process used for the active pharmaceutical ingredient
00:27:55 Understanding the manufacturing process used for the active pharmaceutical ingredient
00:28:55 HPMCAS excipient screening using SEC
00:31:39 Hydroxy ethyl cellulose excipient selection
00:33:41 Excipient grade selection
00:34:37 Conclusion: the OSD deformulation workflow
00:35:32 Thank you for your attentionAny questions?
00:43:29 Contact Information
In this webinar, we explain how Malvern and PANalytical’s unique range of physicochemical analysis techniques can be used to accelerate the development of oral solid dose products, reducing the time to market for new complex generics.

Oral solid dose (OSD) drug products represent the largest class of products sold by the pharmaceutical industry, and as a result represent a significant opportunity for generic companies. Within this, products which have a modified or sustained release profile represent a significant challenge, as deformulation of these requires specific knowledge of the physicochemical properties of the active pharmaceutical ingredient (API) and any functional excipients present within the formulation.

We’ll explain how the range of measurement solutions from Malvern and PANalytical enable critical material attributes such as particle size, shape, structure and composition to be measured, aiding deformulation and rapid formulation development for complex oral solid dose products.

Докладчики

Paul Kippax is Product Group Manager for Micrometrics. A chemist and colloid scientist by background, he first joined Malvern Instruments over 18 years ago as a technical specialist working in the field of acoustics. In 2002 in moved into product management where he used his experienced gained working the pharmaceutical industry to guide the development of the Spraytec and Mastersizer 3000 platforms. He now heads up the team responsible for Malvern’s laser diffraction and imatging product ranges. Paul holds a degree in Chemistry and a PhD in Physical Chemistry.