DOSAGE FORM SAS 1

Drugs

agent intended for diagnosis, mitigation, treatment, cure or prevention of disease.

New Drug

A drug that is not yet proven safe and effective for general use.

Lead Drug

A starting drug with effects but needs improvement or a prototype drug.

Goal Drug

An ideal drug that works well with small doses, few side effects

Prodrug

Works only after body changes it or an inactive drug.

Nonproprietary name

Generic Name

generic name

the chemical name of a drug

proprietary name

brand name

brand name

the name given by the company

Patent

Sole right to exclude others from making, using, or selling an inventory

20 yrs of protection

Trademark

10 yrs and renewable

Therapeutic Index

The ratio of the dose that exerts toxicity in 50% of the population (TD50) to the dose that exerts a therapeutic or effective response (ED50) in 50% of the population.

higher, safer

The_______ the TI, The_______ the drug

formula of therapeutic index (TI)

TI= TD50/ED50

Dosage Forms

The physical form in which a drug is manufactured or administered.

Dosage Form

contains the Active Pharmaceutical Ingredient (API)

Drug Delivery System

the technology or method used to deliver the drug to the body in a way that maximizes its effectiveness and minimizes side effects.

Hippocrates

"Father of Medicine"

Hippocrates

He emphasized clinical observation, ethical medical practice (Hippocratic Oath) and the concept of pharmakon- referring to medicine as a healing substance.

Dioscorides

wrote DE MATERIA MEDICA- describing hundreds of plant based medicine, foundation of pharmacognosy.

Claudius Galen

formulations from natural ingredients. His method of preparing and combining drugs formed the basis of Galenic pharmacy.

Paracelsus

pioneered the use of chemicals in medicine shifting pharmacy from traditional herb based remedies to chemical-based drug therapy.

Karl Wilhelm Scheele

Discovered lactic acid, citric acid, oxalic acid, tartaric acid, and oxygen

Friedrich Serturner

Isolated morphine from opium poppy

Joseph Pelletier and Joseph Caventou

Isolated quinine and cinchonine from cinchona bark , Isolated strychnine and brucine from Nux vomica

Joseph Pelletier and Pierre Robiquet

Co-isolated caffeine, and Robiquet later independently isolated codeine from opium poppy

Discovery and Early testing

A potential drug may come from natural sources, chemical synthesis, once identified, it's tested for pharmacological effects, toxicity, and therapeutic potential.

Preformulation and Formulation

_____________ studies examine the drug's physical and chemical properties

______________studies design the first versions of the dosage form and delivery system.

Discovery and Early Testing

Preclinical Studies

These are lab and animal test done before testing in humans

Clinical Trials

Human testing

6 and 1/2 yrs

Preclinical studies

7 yrs

Clinical studies

IND

Investigational New Drug

NDA

New Drug Application

Phase 1

Safety ,less than 100 people

Phase 2

efficacy, 100-300 people

Phase 3

Confirmation, 300-3000 people

Phase 4

Follow up, several thousand people