Nigel Langley – författare

This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus:  Particle/Globule Size and Distribution,    Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus.  Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make eachof the five chapters uniform in scope and content.Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book.  Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs).  In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development’ crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.

Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus:  Particle/Globule Size and Distribution,    Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus.  Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make eachof the five chapters uniform in scope and content.Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book.  Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs).  In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development’ crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.

This inclusive text describes 3D Printing for pharmaceutical applications, including emerging 3D technologies. The book focuses on the functionality of the materials/biomaterials used for the preparation of dosage forms and devices, fundamentals for preparing these systems and novel applications using these additive manufacturing techniques.  Also, the text includes clinical relevance and regulatory considerations for the future of personalized medicine.Authored by experts with a broad range of experience, extensive insight into the science of 3D printing technology used to produce these systems is provided.  Highlighting viewpoints from the academic, polymer excipient, equipment, product development and regulatory communities, this comprehensive text compiles input from industry thought leaders to illustrate strategies and technologies for applying techniques of additive manufacturing for drug product and device development whilealso providing insight into the path forward for the technology in years to come.

This inclusive text describes 3D Printing for pharmaceutical applications, including emerging 3D technologies. The book focuses on the functionality of the materials/biomaterials used for the preparation of dosage forms and devices, fundamentals for preparing these systems and novel applications using these additive manufacturing techniques.  Also, the text includes clinical relevance and regulatory considerations for the future of personalized medicine.Authored by experts with a broad range of experience, extensive insight into the science of 3D printing technology used to produce these systems is provided.  Highlighting viewpoints from the academic, polymer excipient, equipment, product development and regulatory communities, this comprehensive text compiles input from industry thought leaders to illustrate strategies and technologies for applying techniques of additive manufacturing for drug product and device development whilealso providing insight into the path forward for the technology in years to come.