PHARM 151| UNIT III| INTRODUCTION: SOLID DOSAGE FORMS

Pharmaceutical Dosage Forms and Preparations

I. Introduction to Pharmaceutical Dosage Forms
DRUG PRODUCT
− finished dosage form that contains the active ingredient, generally, but NOT necessarily, in association with one
or more other ingredients
− also includes a finished dosage form that is intended to be used as a placebo
DRUG DELIVERY SYSTEM
− means of administering drugs as formulated preparations
− formulations which provide a therapeutic amount of drug to the proper site in the body promptly and maintain
the desired drug concentration
− products that allow for the uniform release or targeting of drugs into the body
DOSAGE FORMS
− means by which drug molecules are delivered to sites of action within the body
II. The Pharmaceutical Product Development Process
• Research activities directed to the creation of new drugs for new products
• New drugs may be intentionally or accidentally produced from natural sources or by chemical synthesis
• Sequence of Events in Pharmaceutical Product Development
a. Lead compound selection- identifying a promising compound
b. Discovery testing- compound design and testing
c. Pre-clinical research & manufacture research- safety testing in lab animals
d. Investigational New Drug (IND) Application- assessing safety of testing in humans
e. Clinical Trials: Phase I-III- safety and efficacy testing
III. Routes of Drug Administration
• Intravascular • Parenteral administration
A. Intravenous (IV) A. Subcutaneous (SC)- Injected into the subcutaneous
− Injected directly into a vein layer of the skin
− Bolus B. Intramuscular (IM)- injected into muscle layer
− Infusion C. Intradermal (ID)- into the dermis
− Intermittent D. Intraperitoneal (IP)- into the abdominal cavity
− Continuous (peritoneum)
B. Intra-arterial (IA) E. Intraocular (IO)- injected into the eye (vitreous
− Injected directly into an artery humor)
C. Intra-cardiac F. Intrathecal (IT)- into the spinal fluid
− Injected into heart chamber • Others
• Extravascular A. Inhalational- inhalation through the mouth or nose
− Enteral administration B. Topical- applied to the skin for local effect
A. Oral C. Transdermal- applied to the skin for systemic effect
− Into the mouth for swallowing D. Intra-nasal- into the nasal cavity
B. Buccal E. Vaginal- into the vagina
F. Urethral- into the urethra
− Into the buccal cavity
G. Ocular- into the eyes
C. Sublingual
H. Otic- into the ears
− Under the tongue
D. Rectal
− Inserted into the rectum

IV. Importance of a Dosage Form V. Categories of Dosage Forms

✓ Accurate dose • Based on Delivery route
✓ Protection e.g. coated tablets, sealed − Gastrointestinal tract- oral, oropharyngeal
ampules. − Tissue or Body fluids- IV, IA, IC, IM, SC, ID, IT
✓ Protection from gastric juice − Mucosal membrane- otic, nasal, ophthalmic, vaginal, urethral
✓ Masking taste and odor. − Skin surface- topical, transdermal
✓ Placement of drugs within body − Lungs- inhalation
tissues. • Based on General Type of Dosage Form
✓ Sustained release medication. − Liquids- solutions, emulsions, suspensions
✓ Controlled release medication. − Solids-powders, tablets, capsules, patches, gauzes, tapes, sticks
✓ Optimal drug action.
− Semisolids- ointments, creams, gels, pastes, foams, collodions
✓ Insertion of drugs into body cavities
• Based on Release Pattern
(rectal, vaginal)
− Conventional release
✓ Use of desired vehicle for insoluble
− Modified release
drugs.
− Extended
− Delayed
 PHARM 151| UNIT III| INTRODUCTION: SOLID DOSAGE FORMS
VI. Pharmaceutical Excipients
EXCIPIENT
− any component other than the active ingredient in a drug product
− Inactive Ingredient
− provides the drug or active therapeutic agent in a form suitable for administration to a patient with assurance
that the optimum therapeutic effects will result
− role may be to emulsify, stabilize, suspend, preserve, dilute, solubilize, flavor, etc

QUALITIES OF AN IDEAL EXCIPIENT

✓ harmless in amounts used
✓ does not exceed the minimum quantity required to provide their intended effect
✓ does not impair the bioavailability or therapeutic efficacy of the dosage form
✓ does not interfere with the assays and tests prescribed for determining their compliance with official standards
PHARM 151| UNIT III| INTRODUCTION: SOLID DOSAGE FORMS
PHARM 151| UNIT III| INTRODUCTION: SOLID DOSAGE FORMS
PHARM 151| UNIT III| INTRODUCTION: SOLID DOSAGE FORMS
PHARM 151| UNIT III| INTRODUCTION: SOLID DOSAGE FORMS