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    Hadi
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    The document provides a brief history of the pharmaceutical industry, including early uses of plants for pain relief and anesthesia, the discovery of cocaine and its use as an anesthetic, the birth of the modern pharmaceutical industry with William Henry Perkin's accidental dye discovery leading to drug synthesis, and the development of aspirin as the first synthetic drug. It also summarizes the key components of drugs, including active pharmaceutical ingredients and excipients, and discusses good manufacturing practices that are regulated to ensure drug quality and safety.

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    The document provides a brief history of the pharmaceutical industry, including early uses of plants for pain relief and anesthesia, the discovery of cocaine and its use as an anesthetic, the birth of the modern pharmaceutical industry with William Henry Perkin's accidental dye discovery leading to drug synthesis, and the development of aspirin as the first synthetic drug. It also summarizes the key components of drugs, including active pharmaceutical ingredients and excipients, and discusses good manufacturing practices that are regulated to ensure drug quality and safety.

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    © All Rights Reserved
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    3 views16 pages

    Pharmaceutical Industry

    Uploaded by

    Hadi
    The document provides a brief history of the pharmaceutical industry, including early uses of plants for pain relief and anesthesia, the discovery of cocaine and its use as an anesthetic, the birth of the modern pharmaceutical industry with William Henry Perkin's accidental dye discovery leading to drug synthesis, and the development of aspirin as the first synthetic drug. It also summarizes the key components of drugs, including active pharmaceutical ingredients and excipients, and discusses good manufacturing practices that are regulated to ensure drug quality and safety.

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    © All Rights Reserved
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    of 16

    Pharmaceutical

    industry
    Introduction

    Hadia Saif
    CHEM51F20R030
     Surgeries without
    Anesthesia
     Poppy plant (Sumerians,
    6000 years ago)
    Anesthesia
     Great Indian surgeon
    (Sushruta)
     Cannabis plant
     Laughing gas
    Pain alleviation
    • Alcohol and herbal extract mixtures (Rome)
    • Henbane
    • Hemlock
    • Opium
    • Mandrek
    Cocaine

    • 19th century, Inca


    discovered coca leaves
    benefits
    • Anesthetic as well as
    Analgesic
    Birth of the industry

    Quinine
    William Henry Perkin
    Accidental dye discovery
    Company in Germany
    Synthesis of drugs
    • First synthetic drugs
    . • Fever, pain
    Organic synthesis

     1880
     synthetic analgesic
     No addictive properties
     Better alternative of cocaine  Indroduced by Bayer
     Successful in dental procedures
     By Hochst company
    Wonder drug
    anti-inflammatory
    mechanism of elucidation by John Vane
    Structure simplicity
    Heroin as cough sedative 1898
    (addictive properties)
    .
    Drug developmental process
    Synthetic APIs aspirin,
    Natural APIs morphine,
    APIs paracetamol, and many
    antibiotics
    insulin, and penicillin

    • biologically active component


    • desired pharmacological effect

    Biologic APIs monoclonal


    antibodies, vaccines, and Radiopharmaceutical APIs
    gene therapies

    Combination APIs such as Highly potent e.g


    therapies for AIDS and hormones, anticancer
    HIV drugs
    Excipients

    Vehicles for a drug which improve:


     Bulkiness
     Disintegration a) Physiologically inert
     dissolution rate b) Acceptable to FDA
     bioavailability of the drug c) Physiologically and chemically stable
    e) Should not interfere with the
    bioavailability of the drug
    g) Low cost, inexpensive
    h) Meet the standards
    ..

    .
    Diluents Lactose, microcrystalline cellulose, sorbitol

    •.
    Binders Gelatin, glucose, Lactose, cellulose derivatives

    Lubricants Insoluble- Stearic acid, Magnesium stearate,


    Calcium stearate, Talc, Paraffin

    Glidants (Aerosil), Cornstarch, Talc

    Anti- Talc
    adherents
    .
    Super-disintegrants

    • promote moisture penetration​


    • Good hydration capacity​
    • Good compressibility and flow properties​
    • No tendency to form complexes​
    • Modified starches (Sodium starch glycolate​
    • Modified cellulose​
    • Cross-linked poly vinyl pyrrolidone​
    Good
    manufacturing
    practices
    • Guidelines regulated by WHO since
    1975
    • Ensure quality of pharmaceutical
    products
    • GMP: quality seal
    • Good production conditions in
    production area
    • Good testing in quality control
    • Product should not reach in market
    if it violates

    This Photo by Unknown author is licensed under CC BY.


    Basic GMP requirements

    Trained Deviation from


    Manufacturing Changes effecting the
    personnel: production written procedure
    process: properly quality of product:
    , quality control, investigation and
    defined and cotrolled validation
    documentation documentation

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