Gpat

Topics: Solubility, Pharmacology, Solubility equilibrium Pages: 121 (17484 words) Published: April 12, 2014
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.

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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 consideration of Application for the medicinal product. The dose of the drug and the route of administration are important in determining the required modifications and involves development of

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Injectable drug product
Topical drug product
Oral drug product
Vaginal drug products
Nasal drug products
Pulmonary drug products
Final drug product
Considerations in the development of final dosage form include the following Color, shape, size, taste, viscosity, sensitivity, skin feel, and physical appearance of the dosage form
Size and shape of package or container
Production equipment
Production site
Country of origin in which the drug is to be manufactured
Country in which the medicine will be marketed.

Definition
Preformulation studies are defined as the application of biopharmaceutical principles to the physicochemical parameters of drug substance that are characterized with the goal of designing optimum drug delivery system.

Preformulation is the characterization of the physical and chemical properties of the active drug substances and dosage forms. The therapeutic indication of the drug and the route of administration dictate the type of drug product or drug delivery system that needs to be developed. The characterization of drug and its excipient compatibility information decides many of the subsequent events and approaches in formulation development.

Preformulation activities are usually performed during the preclinical stage. However these activities may continue in to phase I and phase II studies. During

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preformulation studies
preformulation scientist.
I)

the

following

information

is

obtained

by

the

Physiochemical characteristics of the drug

II) Solubility characteristics of the drug
IV) Drug-Excipient Compatibility
V) Analytical method developments
VI) Stability studies

I) PHYSIOCHEMICAL CHARACTERISTICS OF THE DRUG:
The physical characterization of the drug involves characterization of various physical...

References: (Pharmaceutical technology November 1997)
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