Pharmaceutical Technology 1/ Industrial Pharmacy 1 Lec. 1 PDF

Pharmaceutical Technology 1 / Industrial Pharmacy 1 Lec.1 Pharmaceutical industry Definition Science & technology of producing pharmaceuticals efficiently & safely on a commercial scale Importance of  Major global...

Pharmaceutical Technology 1 / Industrial Pharmacy 1 Lec.1 Pharmaceutical industry Definition Science & technology of producing pharmaceuticals efficiently & safely on a commercial scale Importance of  Major global economic force Pharmaceutical  Important component of health care system industry  Composed of many public & private organizations  discover, develop, bioeq. Centers, manufacture & market and sales of medicines. N.B Pharmaceutical industry have 2 significant objectives: Perform & conform  complete  Pharmaceutical Industry roots 19th century (18…) with chemical industry  Modern pharmaceutical industry took shape mid 20th century as result in global development in:  Advanced research techniques  Clean/sterile production techniques  GMP & QC guidelines were developed in 1960s  USA market total retail market approaching one trillion-dollars largest single consumer marketplace.  Recent industry mergers & consolidations focused economic power in: multi-national, research driven entitles market share is concentrated in fewer, larger global enterprises. Biopharmaceutical  Fundamentally different from other Manufacturing manufacturing industries.  Fermentation, recombinant DNA technology using living organism to grow target molecules Pharmaco-  Popular Political topic economic  Concerned with forces seeking to overcome drug consumer costs and healthcare cost Branded product original version produced by innovative company that developed the drug. Generic product copy of the original by another company 3 categories of drugs 1. Prescription drugs  that have to be prescribed or administered by healthcare professionals. 2. over the counter  OTC drugs 3. vaccines  which are more complicated in preparation than pharmaceuticals , as it depends on: live bacteria & viruses pg. 1  Pharmaceutical Technology 1 / Industrial Pharmacy 1 Lec.1 “ types of companies:” Brand Innovative companies carry out R&D of new drugs (or contract this process) companies  Initially, their products are protected by patents.  Clinical test data, used for drug approval protected as well. Generic company They produce drugs that they have not developed themselves. Independent  emerged in the 1990s contract  Contract manufactures were initially the source of: manufacturer  chemicals  raw ingredients  Now they have developed new finishing capabilities as well as:  bulk bio and related specialties  novel dosage forms. Biotechnology they have high expectations of these companies companies (Biosimilar not generic) Biosimilar drugs are often confused with Generic drugs... why?? EXAM generic Bio-similar Both are 1. marketed as cheaper versions of costly name-brand drugs 2. available when drug companies’ exclusive patents on new drugs expire. 3. designed to have the same clinical effect as their pricier counterparts Both ↓↓lower the cost of drugs Different at  identical to the original in  not identical but highly similar chemical composition They are close enough to accomplish the  copies of synthetic drugs same therapeutic and clinical result.  modeled after drugs that use living organisms as important ingredients  The primary healthcare regulators (FDA and WHO) are necessary to improve safety profiles.  Regulatory driven manufacturing requirements are presented as Good Manufacturing Practices (GMPs) and cover various items including facilities design, product delivery, and validation. pg. 2  Pharmaceutical Technology 1 / Industrial Pharmacy 1 Lec.1 1- The business of drug development  Branded companies make high investments in R&D to discover new drugs.  The development of new drugs usually starts with: Research phase: discovery of new chemical compounds with a therapeutic effect. Development into an effective, safe treatment and clinical trials Finally, a new drug has to be approved by FDA in case of USA.  Drug approval may take years the first two steps 10 years © Patent protection  for new drugs in which company has exclusive marketing rights.  This period starts at the moment of approval & may be 5 years or more.  During this period companies charge high prices for the drugs to : 1- recover their R&D investments and 2- make high profits. Although only 5% of price  for manufacturing but brand price is high why? 1 and 2  These patents grant the exclusive right to sell & market a specific drug for a specified time period. The whole process may take about 20 years 10 yrs in first two steps and 10 patency for drug product (5 of them patency for clinical result) Why patency for clinical result are only 5 ?to allow generic companies to start study For the approval of a generic  a biological equivalent to brand is req. Generic producers do not have to make high R&D investments and generic competition usually causes a large fall in prices. In the USA competition right after the expiration of a patent. In Europe generics are generally introduced slowly and at ↑higher prices! pg. 3  Pharmaceutical Technology 1 / Industrial Pharmacy 1 Lec.1 Different phases of drug development**IMP Phase Description Test group Cumulative Success Cost size time years rate 5 min Preclinical Identify benefits & risks to Animals 1-2 1%