RESUMEN
On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5-7, 2015.
Asunto(s)
Diseño de Fármacos , Preparaciones Farmacéuticas/normas , Aprobación de Drogas , Humanos , Control de Calidad , Estados Unidos , United States Food and Drug AdministrationRESUMEN
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.
Asunto(s)
Benchmarking/normas , Industria Farmacéutica/normas , Preparaciones Farmacéuticas/normas , Tecnología Farmacéutica/normas , Animales , Química Farmacéutica/normas , Preparaciones de Acción Retardada/normas , Aprobación de Drogas , Industria Farmacéutica/métodos , Excipientes/química , Excipientes/normas , Humanos , Preparaciones Farmacéuticas/administración & dosificación , Preparaciones Farmacéuticas/química , Farmacocinética , Control de Calidad , Medición de Riesgo , Solubilidad , Tecnología Farmacéutica/métodos , Toxicología/normas , Estados Unidos , United States Food and Drug AdministrationRESUMEN
Advancement in the fields of material science, analytical methodologies, instrumentation, automation, continuous monitoring, feed forward/feed back control and comprehensive data collection have led to continual improvement of pharmaceutical tablet manufacturing technology, notably the multi-layer tablets. This review highlights the material attributes, formulation design, process parameters that impact the performance, and manufacturability of the multi-layer tablets. It also highlights on critical-to-quality elements that needs to be addressed in the regulatory submission.
Asunto(s)
Química Farmacéutica/métodos , Comprimidos Recubiertos/normas , Tecnología Farmacéutica/métodos , Animales , Fuerza Compresiva , Humanos , Control de Calidad , Comprimidos Recubiertos/química , Resistencia a la TracciónRESUMEN
The objectives of the present investigation were to prepare and characterize starch acetate (SA) with high degree of substitution (dS) and to study its prospect as film-forming agent in a controlled-release multiparticulate drug delivery system. As a part of the development process by quality by design, the objectives also included identification of critical formulation and process variables that affect the release of a drug. SA, a relatively new polymer, was characterized because it showed good film-forming properties. SA with dS 2.9 was synthesized from corn starch by paste disruption technique. It was compared with the raw material, starch, by Fourier transform infrared spectroscopy, X-ray diffraction, and molecular mass analysis. Viscosity of SA solution increased logarithmically with the polymer concentration. At higher polymer concentrations (1.5-5.0%), the solutions showed pseudoplastic behavior. Among the plasticizers tested, triacetin and triethyl citrate yielded free films with acceptable mechanical properties. The glass transition temperature (Tg) of the films could be well controlled by these plasticizers. Unplasticized film showed a Tg of 31.8 degrees C. A trend was found that increase in triacetin concentration in SA films resulted in increase in permeability coefficient for tritiated water. Scanning electron microscopic photographs showed a clear and smooth plasticized film compared to rough unplasticized film. Dyphylline-loaded beads were coated with highly substituted SA to evaluate the main effects of the formulation and process variables on the release of the drug and to figure out the reliability of the screening design. A seven-factor, twelve-run Plackett-Burman screening design was used. The response variables were cumulative percent of drug released in 0.5, 1, 4, 8, and 12 hr. Quantitative evaluation of the design revealed that coating weight gain, plasticizer concentration, and post-drying temperature had greater influence on the drug release than the others. The main effects on drug release after 12 hr decreased in the following order: coating weight gain (-7.81), plasticizer concentration (4.96), postdrying temperature (-2.51), SA concentration (-0.80), inlet temperature (0.51), postdrying time (-0.31), and atomizing pressure (-0.28).