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
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What are the technological objectives?
- Process control
- stability
- reproducibility
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What does a dosage form contain?
- 1 or more therapeutically active substances
- a number of excipients that can add functionalities
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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
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What happens between administration and action of systemically acting drugs?
- The drug in dosage from has to be released from the dosage form
- The drug has to be dissolved in the aquous solution of the body
- The dissolved drug can now pass the membrane
- It can now enter the systemic blood circulation
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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)
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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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