Concept of Medicine and Dosage Forms

Any product used to diagnose, cure, mitigate, treat or prevent disease

Formulation- The process in which APIs and excipients are combined to produce a medicinal product. 

Nomenclature 

• the brand name-  given by the pharmaceutical R&D company and is a registered (R) name
• the chemical name- API name decided by an expert committee 

Trademark 

Any word, name, symbol or design used in commerce to identify and distinguish the goods of one manufacturer or seller to another and to indicate the source of the goods. 

Infringement- has to be a certain no. pantones away to infringe

• new medicines marketed as a branded product 
• companies take out patents on each new drug they discover to regain money spent on R&D and to make a profit
• standard patent =  20 years, can be extended by an additional 5 

Pharmaceutical R&D Industry 

• convert synthesised chemical compounds into candidate drugs for development 
• development = converting candidate drugs into dosage forms for registration and sale 
• companies need a pipeline of NCEs (new chemical entities)

Blockbuster Drug Model 

• sales over $1 billion p.a.
• pharmacogenomics and personalised medicines 
• big companies now focusing on distribution not development = less future blockbusters

• leading brand loses patent protection 
• much lower profits as drive each others prices down
• government promoting use of generics to slow down increase in health spending 

Generic Drugs

• a drug which is bioequivalent (PK and PD properties) to a leading brand name
• identical dose, route of administration, safety and efficacy
• interchangeable with the branded drug at the pharmacy
• equally effective and can save up to 80% 
• important if there is a shortage of a particular product

Exceptions

• epilepsy medicines- slight differences in rate of absorption = big difference in effect
• modified-release preparations- generic equivalent absorb differently 
• lithium- absorption and activation differences
• biological medicines- copies of these complex medicines (biosimilars) may not automatically be used - need to reference specific manufacturer