Entity

Time filter

Source Type

Pembroke Pines, FL, United States

Parr A.,Glaxosmithkline | Hidalgo I.J.,Absorption Systems LP | Bode C.,Absorption Systems LP | Brown W.,U.S. Pharmacopeial Convention | And 6 more authors.
Pharmaceutical Research | Year: 2015

Purpose: Currently, the FDA allows biowaivers for Class I (high solubility and high permeability) and Class III (high solubility and low permeability) compounds of the Biopharmaceutics Classification System (BCS). Scientific evidence should be provided to support biowaivers for BCS Class I and Class III (high solubility and low permeability) compounds. Methods: Data on the effects of excipients on drug permeability are needed to demonstrate that commonly used excipients do not affect the permeability of BCS Class III compounds, which would support the application of biowaivers to Class III compounds. This study was designed to generate such data by assessing the permeability of four BCS Class III compounds and one Class I compound in the presence and absence of five commonly used excipients. Results: The permeability of each of the compounds was assessed, at three to five concentrations, with each excipient in two different models: Caco-2 cell monolayers, and in situ rat intestinal perfusion. No substantial increases in the permeability of any of the compounds were observed in the presence of any of the tested excipients in either of the models, with the exception of disruption of Caco-2 cell monolayer integrity by sodium lauryl sulfate at 0.1 mg/ml and higher. Conclusion: The results suggest that the absorption of these four BCS Class III compounds would not be greatly affected by the tested excipients. This may have implications in supporting biowaivers for BCS Class III compounds in general. © 2015 The Author(s)


Parr A.,Glaxosmithkline | Hidalgo I.J.,Absorption Systems LP | Bode C.,Absorption Systems LP | Brown W.,U.S. Pharmacopeial Convention | And 6 more authors.
Pharmaceutical Research | Year: 2016

Purpose: Currently, the FDA allows biowaivers for Class I (high solubility and high permeability) and Class III (high solubility and low permeability) compounds of the Biopharmaceutics Classification System (BCS). Scientific evidence should be provided to support biowaivers for BCS Class I and Class III (high solubility and low permeability) compounds. Methods: Data on the effects of excipients on drug permeability are needed to demonstrate that commonly used excipients do not affect the permeability of BCS Class III compounds, which would support the application of biowaivers to Class III compounds. This study was designed to generate such data by assessing the permeability of four BCS Class III compounds and one Class I compound in the presence and absence of five commonly used excipients. Results: The permeability of each of the compounds was assessed, at three to five concentrations, with each excipient in two different models: Caco-2 cell monolayers, and in situ rat intestinal perfusion. No substantial increases in the permeability of any of the compounds were observed in the presence of any of the tested excipients in either of the models, with the exception of disruption of Caco-2 cell monolayer integrity by sodium lauryl sulfate at 0.1 mg/ml and higher. Conclusion: The results suggest that the absorption of these four BCS Class III compounds would not be greatly affected by the tested excipients. This may have implications in supporting biowaivers for BCS Class III compounds in general. © 2015 The Author(s).


Van Buskirk G.A.,Nonclinical Drug Development Consulting Services LLC | Arsulowicz D.,Corium International | Basu P.,Prospect Technology | Block L.,Duquesne University | And 14 more authors.
AAPS PharmSciTech | Year: 2012

In this whitepaper, the Manufacturing Technical Committee (MTC) of the Product Quality Research Institute has updated the 1997 Transdermal Drug Delivery Systems Scale-Up and Post Approval Change workshop report findings to add important new product development and control principles. Important topics reviewed include ICH harmonization, quality by design, process analytical technologies, product and process validation, improvements to control of critical excipients, and discussion of Food and Drug Administration's Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems as well as current thinking and trends on in vitro-in vivo correlation considerations for transdermal systems. © 2011 The Author(s).


Van Buskirk G.A.,Nonclinical Drug Development Consulting Services LLC | Yacobi A.,DOLE Pharma LLC | Bolger M.B.,Simulations Plus Inc. | Chittenden J.,Pharsight | And 17 more authors.
Dissolution Technologies | Year: 2014

This article summarizes the proceeding of the September 2012 Workshop on Application of In vitro-In vivo cor- relation (IVIVC) in Formulation Development. The workshop brought together international experts with the goal of establishing common concepts that could be utilized to facilitate the development and validation of IVIVCs in the registration of and post-approval changes to oral solid dosage forms. The workshop was organized by the Product Quality Research Institute (PQRI) and cosponsored by AAPS, FDA, FIP, and USP. Open access of this information is available to all interested parties.


Van Buskirk G.A.,Nonclinical Drug Development Consulting Services LLC | Asotra S.,AHI Inc. | Balducci C.,Novartis | Basu P.,Prospect Technology | And 26 more authors.
AAPS PharmSciTech | Year: 2014

In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation. Important topics reviewed include International Conference on Harmonization, in vitro-in vivo correlation considerations, quality-by-design approaches, process analytical technologies and current scale-up, and process control and validation practices. It is the hope and intent that this whitepaper will engender expanded dialog on this important subject by the pharmaceutical industry and its regulatory bodies. © 2014 The Author(s).

Discover hidden collaborations