Pharmaceuticals and Bio Pharmaceuticals

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    What are Pharmaceuticals ?A pharmaceutical is a drug that is also referred to as

    medicine ,medication and can be defined as anychemical substance intended for the use in medicaldiagnosis, cure , treatment and prevention of disease .

    It may be also used to enhance the body potential andtrying to the best out of the human body . Can also be

    regarded as supplement .

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    History of Pharmaceuticals The word pharma derives from the Greek word

    pharmakon meaning drug or medicine .

    The earliest drugstores date back to the Middle Ages.The first known drugstore was opened by ArabianPharmacists in Baghdad in 754 and many more beganoperating in the medical islamic world later spread to

    Europe. By the 19th century, many of the drugstores in Europe

    and North America had eventually developed intolarger pharmaceutical companies.

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    Cancer drugs were a feature of the 1970s. From 1978,India took over as the primary center ofpharmaceutical production without patent protection.

    Demand for nutritional supplements and so-calledalternative medicines created new opportunities andincreased competition in the industry.

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    Classification of pharmaceuticals Pharmacokinetics it deals with the study of drug and

    the rate at which it affects the body and the duration ofthe effect .

    Pharmacodynamics It deals with the biochemicaland psychological effects of drugs on the body or onmicroorganisms or parasites within or on the body.

    Pharmacoepidemiology- it is the study of the use andeffects of drugs on large groups of people.

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    Pharmacovigilance - science of collecting, monitoring,researching, assessing and evaluating information ofdrungs on humans

    Pharmaceutical formulation- is the process in whichdifferent chemical substances, including theactive drug, are combined to produce a final medicinal

    product.

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    Classification of Pharmaceutical Drugs

    1. Trentyxicyls : reduces headache .

    2. Antipyretics: reducing fever.

    3. Analgesics: reducing pain (painkillers).4. Antimalarial drugs: treating malaria.

    5. Antibiotics: inhibiting germ growth.

    6. Antiseptics: prevention of germ growthnear burns, cuts and wounds.

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    y we use rugs

    To repair the damaged part.

    To enhance performance .

    To reduce pain . To increase the body resistance .

    To maintain a stability in our body and nervous system.

    To gain physical and mental balance .

    To get a strong immune system .

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    Types of medications : For the digestive system : to faster the metabolism rate

    and increase the digestion activity .

    For the cardiovascular system : to cure the blockspresent inorder to increase the blood flow .

    For pain and consciousness : to reduce the pain orto get unconscious at the time of operations .

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    For muscles : To strengthen the muscles and makethem more strong .

    For skeletons : To reduce the pain in joints and to makethe bones stronger .

    For eye : To protect the eye from infections of dust andair .

    For skin : To prevent skin from any diseases andallergies .

    For nutrition : To increase the vitamins and proteincontent in the body .

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    Side effects of pharmaceuticals Lack of sleep

    High and low blood pressure.

    Hyper tension .

    Severe pain .

    Excessive hunger.

    Headache.

    Eye irritation.Anger .

    Weakness .

    Dehydration

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    Injection or Admnistration of drugs in the body It can be performed in various dosage forms such

    as pills, tablets, or capsules.

    intravenous (into the blood through a vein) and oraladministration (through the mouth).

    all at once as a bolus, at frequent intervals orcontinuously.

    By the medium of food and water .

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    Legal considerationsApproved by International Narcotics Control Board of

    United nations .

    Patented and liscened Drugs . In India approved by FDA ( Food and Drug

    Assocoation) .

    Central Drugs Standard Control Organization

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    Evironmental Impact

    Contamination of water .

    May also be deposited in the environment through

    improper disposal, runoff from sludge fertilizer andreclaimed wastewater irrigation, and leaky sewage.

    filtered ineffectively by wastewater treatment plants.

    In the bodies of plants and animals .

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    What are BiopharmaceuticalsBiologically significant compounds like

    hormonesand proteinsuseful for treatment of

    variety of human health disorders, usually calledas Biopharmaceuticals or Biotherapeutics orBiologicals, usually obtained from biological

    source and produced through industrial

    biotechnology

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    Insulin- hormone which lowers bloodsugar; used by diabetics

    Interferon- class of cytokines effective vs viralinfections

    Factor VIII- blood protein necessary for clotting;missing in hemophiliacs

    Streptokinin - bacterial enzyme to dissolve bloodclots in coronary arteries

    Beta endorphins- pain suppressors

    Important Biotherapeutics

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    More than 30 recombinant therapeutics havebeen approved globally for commercial use andseveral are on the way

    In India, 12-15 of these are presently being marketed.Many of these are being imported (excepting fewlike Hepatitis B vaccine, Insulin etc.) and consumed

    and now several are underway for indigenousproduction

    Globally approved recombinant therapeutics are

    broadly categorized into blood factors, hormones,growth factors, interferons, interleukins, vaccinesand other miscellaneous therapeutic products

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    Some approved Therapeutics

    The products of rDNA technology

    Hormones Growth hormone, Insulin, Calcitonin, FSH

    Cytokines

    Interferons (Interleukins), EPO, CSF,Neurotrophic factors

    Clotting factors Factor VIII, Factor IX

    Vaccines Hepatitis B, acellular pertussis vaccine

    (Bordatella pertussis,whooping cough)

    Monoclonal antibodies

    http://www.answers.com/topic/whooping-coughhttp://www.answers.com/topic/whooping-cough
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    The commercial production of recombinantBiologicals and therapeutics now became animportant area in global industralization

    The process developed in production oftherapeutics has to be taken to industrial scalefor implementing these developed process inindustrial scale and to get viable industrial

    production of these therapeutics orbiologicals mainly through Fermentationtechnology

    Commercial production of Therapeutics

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    Pilot scale Fermenter

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    Insulin is an important hormone which regulatessugar metabolism

    An inability to produce insulin results in a form of

    diabetes, this disease can be treated by dailyinjections of insulin

    Historically, insulin from pigs or cows is used, butknown to produce immune reactions in somepatients

    Challenge: how to make human insulin to be usedas a drug in cell systems or microbes?

    Insulin - first recombinant proteinto be produced

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    Idea: take the gene of human insulin, clone into aplasmid, introduce the plasmid into E. coli or cells,and use them E.coli as BiologicalFactory for insulinproduction

    Amino acid sequence produced insulin (Contains 51amino acids) and is identical to that of the naturalhuman protein and it will not cause any immunereactions

    Much more economical than attempts to produceinsulin by chemical synthesis

    Recombinant Insulin overcome manyproblems

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    Owen Mumford Ltd., UK

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    Penicillin G (Benzyl penicillin)R = benzyl group

    History of Penicillin

    - Modern era of antibiotic discovery- Inhibiting the formation of peptidoglycan cross-links in the bacterial

    cell wall : Inhibition of DD-transpeptidase

    http://images.google.co.kr/imgres?imgurl=http://botit.botany.wisc.edu/images/332/Deuteromycetes/Penicillium_D_pa_sw_so_sl/Penicillium_conrdiophores_tjv.gif&imgrefurl=http://botit.botany.wisc.edu/images/332/Deuteromycetes/Penicillium_D_pa_sw_so_sl/Penicillium_conrdiophores_tjv.html&h=480&w=655&sz=245&tbnid=2gb5hHon0ACIpM:&tbnh=101&tbnw=138&prev=/images?q=penicillium&um=1&start=1&sa=X&oi=images&ct=image&cd=1
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    Biosynthesis of Penicillin G in Fungus

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    Alexander Fleming was trying to isolate the bacterium, Staphylococcusaureus by

    growing it on the surface of nutrient at St. Marys Hospital in 1928 : Breakthroughin antibiotic history

    - He noticed that no bacteria grew near the invading substance in thecontaminated plate. : Meaningful finding, not a failed experiment

    - He thought the cell killing must be due to an antibacterial agent

    - Identification of foreign particles as common mold of the Penicillium genus(later identified as Penicillium notatum)

    - Recovery of a tiny quantity of secreted material using the crude extractionmethods

    - Secreted material : powerful antimicrobial activity and named penicillin

    - The discovery laid essentially dormant for over a decade

    World War II resurrected the discovery : desperate demand an antibiotic

    with minimal side effects and broad applicability

    Howard Florey and Ernst Chain of Oxford : rebuilt on Flemings observation

    Discovery and development

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    Human growth hormone (hGH, or Somatotropin)

    Secreted by the pituitary gland, and is responsiblefor normal body growth and development, bystimulating protein production in muscle cells,energy release from the breakdown of fats andstimulates the development of bones

    These processes together are responsible forlongitudinal growth. Inadequate production of GHresults in short stature, defined as a below normalheight for a given age

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    In children and adolescents, the rate of growthin height is primarily determined by the rate atwhich endogenous GH is secreted

    The growth spurt during puberty is caused by

    increased secretion of GH

    Under normal conditions, GH secretion and

    growth rate remain increased until final heightis reached, after which GH secretion is reducedto a steady state

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    Production of hGH

    Purification of recombinant human growthhormone (rhGH) from Chinese hamster ovary(CHO) cell culture supernatant by Gradiflow

    large-scale electrophoresis is described.Production of rhGH in using E. coli as analternative for using CHO cells, with theadvantage that rhGH is secreted into protein-freeproduction media, facilitating a more simple

    purification and avoiding resolubilization ofinclusion bodies and protein refolding. proteins

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    Erythropoietin

    Human Eryhtopoietin is produced in kidney

    A glycoprotein, acts on the bone marrow toincrease the production of red and whiteblood cells. Stimuli such as bleeding or

    moving to high altitudes (where oxygen isscarce) trigger the release of erythropoietin

    Known as EPO, MW 30400 Kda, 165 amino

    acids in human (192 Mouse)

    Has been widely used in AIDS fordevelopment of immunity

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    Kidney is the principalproduction site of Erythropoietin

    Bones like Femur, Tibia, Vertebra,Sternum, Rib produce most RBCand WBC under the influence ofEPO

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    When EPO is produced

    When RBC count comes down(Oxygen level decreases) in the blood

    It will result in

    Kidney cells specifically sense theoxygen deficit in the blood and startproducing Erythropoietin

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    EPO also has therapeutic Abuses

    Used in sports toimprove endurance

    Now detected fromnaturally occurringEPO by protein

    markers producedduring post injectionphase

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    Biotherapeutics are delicate drugs Much larger and more

    complex than traditionalpharmaceuticals

    Composed of unstableproteins with a precisestructure

    Easily damaged byunfavorable temperaturehistory during storage

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    Even insulin has temperature problems

    Insulin is a verytemperature stablebiotherapeutic

    A graph of storage life vstemperature shows asawtooth peak

    The product dies at bothtemperature extremes

    Insulin Shelf-life

    0.1

    1

    10

    100

    1000

    -20 0 20 40 60

    Temperature (C)

    Months

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    Effect of temperature storage extremes< 0o C

    Freezing

    Protein denaturation

    Formation of aggregates

    Loss of functionalactivity

    Formation of potentially

    hazardous immunogenicbyproducts

    > 8o

    C

    Chemical side reactions

    Protein denaturation

    Formation of aggregates

    Loss of functional activity

    Formation of potentiallyhazardous immunogenic

    byproducts

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