MODULE 5

Goal drug

“Ideal or Standard Drug”

Lead Compound

Has a desired biologic or pharmacologic activity
Prototype chemical compound

ACTIVE but may not possess all of the desired features of goal drug

Prodrugs

Requires metabolic biotransformation after administration to produce the desired pharmacologically active compound

New Drug (FDA Definition)

Any drug that is not recognized (by official monographs) as being safe and effective in the conditions recommended for its use

Phase 1 Clinical Trial

20-100 healthy volunteers (Safety)
To discover if the drug is safe in humans

Determine what safe dosing range is & if it should move on to further development

Phase 2 Clinical Trial

Test in small groups of patients

To evaluate the candidate drug's effectiveness with the disease under study

To examine the possible short-term effects of the drug

To analyze optimal dose strength and schedules for using the drug

Phase 3 Clinical Trial

Test in large group of patients to show safety & efficacy

To generate statistically significant data about safety, efficacy and overall risk-benefit relationship of the drug

To provide basis for labelling instructions to help ensure the proper use of the drug

Informed Consent

Document of agreement given to the volunteers (Phase 1-3) agreeing to the clinical evaluation to push through.

Phase 4 (Pharmacovigilance/Post Marketing Surveillance)

Public/patients, community for commercial use

To continue monitoring and submitting periodic reports to FDA

To require companies to conduct additional studies on an approved drug

Drug

Any article intended for use in diagnosis, mitigation, cure, treatment & prevention of dose (DMCTP) in man & animals

Excipients

Inactive components (non-therapeutic ingredients)

Make Drug more appealing & efficacious

Placebo

A DF that does not contain an API

For clinical trial (comparative studies)

Drug Delivery System

Uniform release of products

Transdermal patches – OROS ( Osmotic Release Oral Delivery System)

Cosmetics

Any subs/preparation intended to be placed in contact with the external parts of the human body (teeth or mucous membrane of the oral cavity) - e.g: mouthwash

Compounding

“Extemporaneous compound”

Preparation, mixing, packaging & labeling of a drug to prepare an individualized drug treatment for a px

Suspension

Dispensing insoluble solid particles/materials

Emulsion

Dispersed immiscible liquid

Purified Water

For non-sterile products; Rx and manufactured products

Main solvent for all DF - Obtained by distillation, ion-exchange or reverse osmosis - pH 5-7 - Used in prescription and manufactured finished products except parenteral and other sterile solutions

Water for Injection (WFI)

Purified water that is FREE of pyrogens - Obtained by distillation or reverse osmosis - Used for the preparation of parenteral solutions

Sterile Water for Injection (SWFI)

WFI that is sterilized and packaged in single-dose containers < 1L

Bacteriostatic Water for Injection (BWFI)

- SWI that contains 1 or more antimicrobial agents - Packaged in single or multiple-dose containers (vials) < 30ml ● Example: Neomycin

Sterile Water for Inhalation

- Water purified by distillation or reverse osmosis and rendered sterile - It contains no antimicrobial agents - Not used for the preparation of parenteral solutions or other sterile dosage forms

Sterile Water for Irrigation

- Contains water that is sterilized and packaged for use as an irrigant (Washing/Rinsing). - No antimicrobial agent or other Substance has been added. - WFI that is sterilized and suitably package

Acidic

inhibit germination & outgrowth of bacterial spores

Neutral

disrupts lipid structure of cell membrane( lysis)

Mercurials

binds to sulfhydryl compounds

QUATS (Quaternary Ammonium Compounds)

inactivation of energy producing enzyme (cell membrane disruption)

Astringents

Styptic/toner - shrink skin pores or precipitate proteins

Aluminum Acetate Topical Solution (Burrow’s solution)

contact dermatitis (antiseptic)

Lime Water/Calcium Hydroxide T.S

antacid, astringent, saponifying agent

Coal Tar T.S

Unpleasant appearance and odor, nearly black viscous liquid with naphthalene odor

eczema

Douche

Used as a cleansing agent or antiseptic for body cavity

Saline laxatives

draw water to intestines

Osmotic laxatives

add weight to colon = evacuate

Sedative laxative

Cause independence

Syrups

Solutions containing high concentration of sucrose or other sugars

Linctus

Cough, throat condition

Honeys

Apis mellifera

Mucilages

Dispersion of gum in water

Jellies

imbibe in water or swell in water

Elixirs

Clear, sweetened or flavored hydroalcoholic solutions intended for oral use

Tinctures

Alcoholic/hydroalcoholic solutions prepared from vegetable drugs or chemical substances

Spirits/Essences

Hydroalcoholic solutions of volatile oils

alcohol content: 50-90%

Fluidextracts

"100% Tinctures" - very potent

Liniments/Embrocations

alcoholic or oleaginous solutions containing more than 1 API & are usually rubbed on the skin

Gels

Thixotropic in nature