Gpat
Formulations and Formulation
Development
Pre-Formulation Studies
Incompatibilities encountered in drug multi-component combinations and /or
Drugexcipient Compatibility.
Pharmaceutical Formulation Additives, Containers and Closures.
Manufacturing and Quality control of Solid Dosage forms, Semi-Solid Dosage forms,
Liquid Dosage forms, Sterile Dosage forms, Metered Dosage forms (Aerosols)
Study of principles, Production techniques, Pilot batch studies, Scale-up Studies, Transfer of technology to commercial scale batches, stability conditions.
Storage and handling of In-Process and finished dosage forms, principles of stability studies as per ICH Guidelines.
1
PREFORMULATION STUDIES
INTRODUCTION:
All the medicinal products or dosage forms will contain the drug plus a variety of additives or excipients whose role is to enhance the product performance without altering the stability and pharmacology of the drug. It is therefore, a general rule that patients are never administered a drug but rather a medicinal product that contains the drug.
Pharmaceutical development of a medicinal product must retain the drugs promising invitro pharmacological activity and provide a predictable in-vivo response. The marketed product must be stable, correctly packaged, labeled and easily administered, preferably by self administration. The development of pharmaceutical product involves multiple skills, processes and stages and is, therefore, a large undertaking requiring extensive resources.
The development of medicinal product consists of several stages such as
Preformulation
The study involves Characterization of physicochemical properties and includes extensive study of
Physiochemical characteristics of the drug
Solubility characteristics of the drug
Drug-Excipient Compatibility
Analytical method developments
Stability studies
Formulation development
Formulation development is a continuing process which is attempted by the manufacturer after NDA
Development
Pre-Formulation Studies
Incompatibilities encountered in drug multi-component combinations and /or
Drugexcipient Compatibility.
Pharmaceutical Formulation Additives, Containers and Closures.
Manufacturing and Quality control of Solid Dosage forms, Semi-Solid Dosage forms,
Liquid Dosage forms, Sterile Dosage forms, Metered Dosage forms (Aerosols)
Study of principles, Production techniques, Pilot batch studies, Scale-up Studies, Transfer of technology to commercial scale batches, stability conditions.
Storage and handling of In-Process and finished dosage forms, principles of stability studies as per ICH Guidelines.
1
PREFORMULATION STUDIES
INTRODUCTION:
All the medicinal products or dosage forms will contain the drug plus a variety of additives or excipients whose role is to enhance the product performance without altering the stability and pharmacology of the drug. It is therefore, a general rule that patients are never administered a drug but rather a medicinal product that contains the drug.
Pharmaceutical development of a medicinal product must retain the drugs promising invitro pharmacological activity and provide a predictable in-vivo response. The marketed product must be stable, correctly packaged, labeled and easily administered, preferably by self administration. The development of pharmaceutical product involves multiple skills, processes and stages and is, therefore, a large undertaking requiring extensive resources.
The development of medicinal product consists of several stages such as
Preformulation
The study involves Characterization of physicochemical properties and includes extensive study of
Physiochemical characteristics of the drug
Solubility characteristics of the drug
Drug-Excipient Compatibility
Analytical method developments
Stability studies
Formulation development
Formulation development is a continuing process which is attempted by the manufacturer after NDA
References: (Pharmaceutical technology November 1997)