1. FIRDAUS HAFIZAH SOFIA AINIZA
NUTRACEUTICAL FORMULATION TECHNOLOGY HHV UNIT 1: PREFORMULATION & PREPARATION OF RAW MATERIAL 1.3 TESTING REQUIREMENT
FIRDAUS HAFIZAH SOFIA AINIZA

2. INTRODUCTION
Preformulation testing is the first step in the rational development of dosage forms.
It can be defined as an investigation of physical and chemical property of a drug substance alone and when combined with excipients.
Physiochemical properties are those that can be determined from in vitro experiments.

3. OBJECTIVE
To generate information useful to the formulation in developing most stable and availability dosage form that mass can be produced.

4. WHY IS PREFORMULATION IMPORTANT?
It describes the process of optimizing the delivery of drug thorough determination of physical, chemical properties of new drug molecule that affect drug performance and development of an efficacious stable and safe dosage form.
Preformulation studies on a new drug molecule provide useful information for subsequent formulation of a physicochemically stable and biopharmaceutically suitable dosage form.

5. Physicochemical Properties
Dissolution
To know the gastrointestinal absorption & other physicochemical properties.
Drug stability
Compatibility
It is important for the formulator of a new drug substance to know with which excipients he can work and which he cannot.
Bulk properties
Particle size
Powder flow property
Hygroscocity
Solubility analysis
Aqueous solubility
Drug pka / ionization at physiological ph
Partition coefficient

6. Analytical Measures
Microscopy
Spectroscopy
Chromatography

7. REFERENCES
Banker GS, Rhodes CT., Modern pharmaceutics, 4th ed. New York: Marcel Dekker; p
Alfred Martin., Physical pharmacy. 4th ed. New York: Lippincott Williams & Wilkins; p
Remington, The Science and Practice of Pharmacy, 20th Edition, B.I Publication Pvt Ltd.p
Leon Lachman, Herbert AL, Joseph LK., The theory and practice of industrial pharmacy, 3rd ed. Bombay: Varghese publishing house; p