Application of biopharmaceutics classification system in formulation developm...Surang Judistprasert
The document discusses the application of the Biopharmaceutics Classification System (BCS) in formulation development. It describes the four BCS classes based on a drug's solubility and permeability properties and how these properties impact bioequivalence studies and regulatory requirements. It also discusses factors that influence the predictability of in vivo performance based on the BCS class, such as first-pass metabolism and excipient effects. Recommendations are provided for designing successful bioequivalence studies using BCS principles.
The document discusses using 7QC tools for experiment design and problem solving. It lists 7QC tools like Pareto charts, histograms, process flow diagrams, check sheets, scatter diagrams, control charts, and run charts. These tools can be applied in design of experiments (DOE) to investigate the relationship between input attributes, process parameters, and output attributes. Minitab software can be used for DOE. Results from DOE like scatter diagrams can study the effect of parameters on quality attributes. Pareto charts can identify and prioritize problems, showing that 20% of causes often create 80% of issues. The document gives an example of using these tools to analyze quality problems with ACE tablets.
This document discusses Quality by Design (QbD) and how to implement it in a practical way. It defines QbD and outlines the key steps, which include establishing a target product profile, identifying critical quality attributes, defining a design space, control strategy, validation, and lifecycle management. Design spaces can be defined using design of experiments or multivariate analysis of historical data. Tools like DOE and MVA are useful for establishing and monitoring the design space. The document provides an example target product profile and discusses how to set the profile and manufacturing process scheme based on the active pharmaceutical ingredient's properties. It also discusses using risk assessment to identify critical variables and control strategies. The overall goal is developing a robust process understanding and control
Thai version. This material was for 3rd seminar last year. I would like to introduce innovation management for our colleague and challenged them in knowledge management in our department.
This document summarizes a presentation on quality culture given at the 2012 CGMP Conference in Baltimore. The presentation discusses the importance of quality culture in protecting patient safety and product quality across complex pharmaceutical supply chains. It defines quality culture as an environment where everyone understands and embraces their responsibility for quality. Strong quality culture is identified as the most important indicator of an organization's ability to consistently deliver high quality products and services.
The document discusses alternative materials to gelatin capsules, including starch and HPMC capsules. It describes how starch capsules are produced via injection molding and have similar fill volumes to gelatin capsules. HPMC capsules are made using the same process as gelatin capsules. The document also provides details on the manufacture and benefits of soft gelatin capsules, which combine advantages of liquid and solid dosage forms. Soft gelatin capsules offer improved content uniformity, safety, stability, and bioavailability compared to other forms.
This document discusses study design considerations for comparing topical dosage forms in vitro and in vivo. It outlines three methods approved by the Thai FDA to check bioequivalence of topical drugs: in vitro drug release testing using Franz cell diffusion, pharmacodynamic studies measuring physiological effects, and clinical trials. The US FDA only approves clinical trials. In vitro methods are useful but human studies with 100-4000 subjects are ultimately needed to adequately assess bioequivalence of topical dosage forms.