PRESENTATION OF DOSAGE FORM DESIGN

SUBMITTED TO SUBMITTED BY

WHAT IS PRE FORMULATION?

phase of a research and development process where the pre formulation scientist characterizes the physical, chemical and mechanical properties of a new drug substances in order to develop stable, safe and effective dosage form

IMPORTANCE

Through pre formulation work is the foundation of developing robust formulation Good pre formulation will inevitable lead to simple and elegant formulation and successful commercial product

GOAL OF PRE FORMULATION

To establish the physicochemical properties of new drug To establish the data on drug-excipient compatibility

To establish its kinetic rate profile

ORGANOLEPTIC PROPERTY

Being, affecting, or relating to qualities (as taste, color, odor, and feel) of a substance (as a food or drug) that stimulate the sense organs Additives are required to be added while dispensing the prescription in order to make the preparation more palatable and safe during its use Dont have any therapeutic activity Serve as aid to drug formulation

COLORING AGENTS

For identification of preparations To increase acceptability to patients

To give warning
To provide standard preparations

TYPES OF COLORING AGENTS

Mineral color - iron oxide, carbon black, titanium dioxide Natural colors from plants and animals cochineal, carmine, caramel Coal tar colors amaranth, erythrosine, green S, orange G patent blue and tartrazine

COAL TAR COLORS

Permitted FD and C coal tar dyes are used as coloring agent in pharmacy These dyes are readily soluble in water and have good stability to PH and light Examples naphthol blue black 20470, brilliant blue FCS 42090, eosine G 45380, sudan III 26100

FLAVOURING AGENTS

Mask the unpleasant taste and odor to the preparation An objectionable taste may lease to nausea and vomiting, thus discourage the patient to take the medicine regularly On the order hand, attractive flavor will encourage the continuation of the treatment The taste buds of the tongue are sensitive to a number of basic tastes i.e. alkaline, acid, bitter, metallic, salty and sweet

TYPES OF FLAVOURS

Sweetening agents Flavored syrups

Aromatic oils
Synthetic flavors

SWEETENERS

To overcome the bitterness or unpleasant taste of the drug Adjustment of taste is essential for oral preparations Commonly used sweetening agents sucrose, invert syrup, sorbitol, saccharin sodium, sodium cyclamates