Summary: Biopharmaceutical Technology And Biopharmacy 1

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  • Les 1: Biopharmacy

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  • How are the dosage forms designed?

    They are designed with the biopharmaceutical- and the technological objectives
  • What describes the formulation of a drug?

    The formulation is a qualitative and a quantitive composition of the content of a medicine: API with an intrinsik pharmacologic activity with an excipient. From this, they are making a dosage form.
  • What are the biopharmaceutical objectives?

    • Release profile
    • Route of administration
    • Targetting
  • What are the technological objectives?

    • Process control
    • stability
    • reproducibility
  • What does a dosage form contain?

    • 1 or more therapeutically active substances
    • a number of excipients that can add functionalities
  • How is the therepauteitc efficacy of a drug substance determined?

    • Intrinsic pharmacological and toxicological properties of the substance (stof)
    • The extend (omvang) and rate (snelheid) of delivery of the substance to the site of action
  • What happens between administration and action of systemically acting drugs?

    1. The drug in dosage from has to be released from the dosage form
    2. The drug has to be dissolved in the aquous solution of the body
    3. The dissolved drug can now pass the membrane
    4. It can now enter the systemic blood circulation
  • Why must the drug dissolve in the gastrointestinal tract?

    Because only dissolved drugs can pass the absorptive membrane and come in the blood circulation.
  • There are exceptions of first dissolving the drug before absorption, what are those?

    • Intravenously injected drugs
    • Targeted drugs
    • Locally applied and locally acting drugs (dermal/nasal/inhaled drugs)
  • You can split the pharmacokinetics into 4 different processes, what are those?


    ADME processes.
    Absorption: uptake of drug in systemic blood circulation
    Distribution: the distribution (verdeling) of the drug to the different compartments in the body
    Metabolism: the chemical conversion (omzetting) of a drug substance by the body to different active/inactive substances (metabolites)
    Excretion: removal of the drug/its metabolites from the body via urine, bile, sweat or breath
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