HHM 5014 NUTRACEUTICAL FORMULATION TECHNOLOGY UNIT 3 : NUTRACEUTICAL DOSAGE FORM SUB-UNIT : PHARMACEUTICAL & FORMULATION CONSIDERATION SIR SYAHRIN LUQMAN SYAMIMI AZALEA LIANA

INTRODUCTION Pharmaceutical technology Discipline of pharmacy that deals with the process of turning a new chemical entity into a medications to be used safely and effectively by patiens.

WHY NEED? To protect the drug substance from the destructive influences of atmospheric oxygen or humidity (coated tablets, sealed ampuls) To protect the drug substance from the destructive influence of gastric acid after oral administration (enteric-coated tablets) To provide clear liquid dosage forms of substances (syrups, solutions) To conceal the bitter, salty, or offensive taste or odor of a drug substance (capsules, coated tablets, flavored syrups)

THE PURPOSE OF PROVIDING THE MECHANISM FOR THE SAFE AND CONVENIENT DELIVERY OF ACCURATE DOSAGE To protect the drug substance from the destructive influences of atmospheric oxygen humidity To provide for optimal drug action through inhalation therapy To provide for placement of drugs directly in the bloodstream or body tissues (injections)

PREFORMULATION STUDIES Before the formulation of a drug substance into a dosage form, it is essential that it be chemically and physically characterized Types :- a) physical description b) microscopic examination c) drug & drug product stability

CONT’ Physical description Physical properties include such characteristics as its physical description, particle size, crystalline structure, melting point, and solubility. Microscopic Examination Important step in pre-formulation work, It gives an indication of particle size and size range of the raw material along with the crystal structure. Drug and Drug Product Stability Stability is the extent to which a product retains within specified limits and throughout its period of storage and uses.

FIVE TYPES OF STABILITY CONCERN PHARMACISTS Chemical Each active ingredient retains its chemical integrity and labeled potency within the specified limits. Physical The original physical properties, including appearance, uniformity, dissolution, and suspend ability are retained. Microbiologic Sterility or resistance to microbial growth is retained according to the specified requirements. Antimicrobial agents retain effectiveness within specified limits. Therapeutic The therapeutic effect remains unchanged Toxicologic No significant increase in toxicity occurs.

CONCLUSION Each type of dosage form is unique in its physical and pharmaceutical characteristics. The proper design and formulation of a dosage form requires consideration of the physical, chemical, and biologic characteristics of all of the drug substances and pharmaceutical ingredients to be used in fabricating the product.

REFFERENCE