Certificate course planned for launch in 2014.
Drug molecules are rarely administered alone. They are administered as dosage forms or formulations. Before any formulation development is initiated, the drug molecule is characterized for certain fundamental physical, chemical properties and physico-technical properties. A thorough understanding of these properties allows science based development of formulations, by enabling identification of challenges during formulation development. These activities, done prior to initiation of formulation development are called as pre-formulation studies. Pre-formulation can be considered as the learning phase about the molecule.
We have developed a course titled “Pharmaceutical Preformulation: Basics and Industrial Applications” to provide a basic understanding of the role of preformulation studies in drug discovery, drug development and development of generic products. This course shall help in a theoretical understanding of the topic and its application in an industrial formulation development setting.
Course content by Dr. Arvind Bansal, NIPER
The course has been developed by our new guest faculty Dr Arvind Bansal, who is a leading academician and pharmaceutical scientist. He is the Professor and head Department of Pharmaceutics at the National Institute of Pharmaceutical Education and Research, Mohali, India, where he leads a research group focusing on preformulation, solid state characterization and pharmaceutical development. He has rich industrial experience, in reputed groups such as Ranbaxy Research Laboratories and JK Pharmaceuticals (now taken over by Teva Pharmaceuticals). He has authored over 85 research papers, 31 patents and has made over 63 conference presentations. He has also successfully completed more than 250 industry projects in the field of preformulation studies and formulation development.
This course work shall be covering the following contents –
- Introduction to Pharmaceutical Preformulation
- Role of Preformulation Studies in Drug Discovery
- Role of Preformulation Studies in Drug Development
- Aqueous solubility
- Stability Studies
- Solid State Properties
- Compaction Studies
- Compatibility Studies
- Pre-Formulation Report
- Preformulation Studies for Generic Products
Please fill the form below to join this course. The course will be delivered to you as 11 modules, as individual mails, one mail every 3-4 days so you can fully understand and absorb the information provided.
I hope you will enjoy the course and gain valuable insights in to the field of Pharmaceutical Preformulation.
Join Free E-Course on Preformulation Studies Now!!
Here below is given the free online e-course on Preformulation Studies
Module 1 : Introduction to Pharmaceutical Preformulation
What is Preformulation?
Drug molecules are rarely administered alone. They are administered as dosage forms or formulations. Formulation development can be involved at various stages like animal studies, first time in human studies, clinical trials and commercialization of the product. Before any formulation development is initiated, the drug molecule is characterized for certain fundamental physical, chemical properties and physico-technical properties….
Module 2 : Role of Preformulation Studies in Drug Discovery
What is Drug Discovery?
Drug discovery and development is a multi – disciplinary activity involving inputs from various departments like medicinal chemistry, molecular biology, pharmacology, toxicology, pharmacokinetics and pharmaceutical development. The average time from drug discovery to product launch is almost 10 to 12 years. Drug discovery is defined as the process by which drugs are discovered or designed. Drug development is a term used to describe process of bringing a new drug to market, after drug candidate has been selected in drug discovery……
Module 3 : Role of Preformulation Studies in Drug Development
Part – 1
What is Drug Development?
Drug development involves investigations on ‘lead molecules or candidate molecules’ identified in drug discovery stage. These investigations mainly involve clinical evaluation. Clinical trials (CTs) are conducted in human subjects and involve phase I, II and III. Phase IV trials involve post-marketing surveillance of the new drug….
Module 4 : Aqueous solubility
Components of Solubility Studies
Solubility is one of the most critical preformulation properties that have a significant impact on performance of a molecule. Solubility and permeability form the backbone of Biopharmaceutics Classification System (BCS) that provides scientific framework for designing of drug delivery systems and many regulatory decisions. Solubility assessment is one of the first most important and extensively studies, preformulation parameter….
Module 5 : Permeability
Biopharmaceutics Classification System
Permeability along with solubility forms the scientific basis of Biopharmaceutics Classification System (BCS). Oral absorption involves permeability across intestinal membrane. USFDA document defines permeability as ‘effective human jejunal wall permeability of drug and includes apparent resistance to mass transfer to intestinal membrane’….
Module 6 : Stability Studies
Types of Stability Studies
Inherent stability of drug substance is a critical component of preformulation studies and provides numerous inputs for development of the drug product. Various stages like processing, storage and gastrointestinal milieu, challenge the stability of a drug substance. A typical preformulation protocol involves studies to assess chemical stability, physical stability and photostability….
Module 7 : Solid State Properties
Levels of solid state properties
A vast majority of APIs and excipients are used in the solid form and their solid sate properties have an impact on their stability and performance. Solid state properties can be envisaged at three levels – molecular, particle and bulk.
Solid State Properties
Molecular level of solid state
Molecular level deals with the arrangement of the individual molecules in the solid form and involves phenomenon like crystalline, polymorphism, solvated state, amorphous form and co-crystals….
Module 8 : Compaction Studies
Role of Compaction Studies
Tablet is one of the most common dosage forms because of obvious advantages of ease of administration, easy commercial manufacturing and stability. Manufacturing of tablets involves a step of compaction wherein the bulk powder or granules are converted to a compact mass, under compaction pressure in a tablet press. Hence it is desirable that the drug substance has acceptable compaction profile….
Module 9 : Compatibility Studies
Compatibility studies for selection of excipients
Compatibility studies are usually the last activity done during pre-formulation profiling. All pre-formulation studies, except compatibility studies, are carried out on pure drug substance. Compatibility studies are aimed at studying the interactions of drug substance with other excipients. Selection of excipients is vital for development of a quality drug product. Choice of excipients is guided by the type of proposed dosage form….
Module 10 : Pre-Formulation Report
Identification of Challenges for ‘Drugability’
Preformulation studies play a critical role during drug discovery and development process. It is customary to generate a document called preformulation report, on culmination of experimental protocols. Pre formulation report during drug discovery presents an assessment of impact of solubility, permeability and stability on ‘drugability’ of the molecule. In case any parameter poses a risk to drugability, strategies to mitigate that risk are discussed in the preformulation report….
Module 11 : Preformulation Studies for Generic Products
What is a Generic Product?
A generic product is defined as “a drug product that is comparable to branded innovator product in dosage form, strength, route of administration, quality and performance characteristics and intended use”. As per the description given in USFDA, a generic product is pharmaceutical equivalent and bioequivalent to the innovator product. A generic product in simple terms is a duplicate of the innovator product….