Questions and Answers
Which factor was found to be important for the absorption of the micronised drug in the Steroid Oral BA study in rats?
Choice of vehicle
In the BA study of lipophilic pro-drugs of phenytoin in rats after gastric administration, which factor led to a 4-fold increase in bioavailability compared to the solution of phenytoin sodium?
Solution in short chain fatty acid
In the BA study of the antimalarial amine in beagle dogs, which formulation resulted in a 4-fold increase in bioavailability compared to the standard capsule?
Oleic acid solution
What technique was used for preparing lipid nanoparticles for various lipophilic drugs as mentioned in the text?
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What is the Biopharmaceutics Classification System (BCS) based on?
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Which class of drugs in the BCS has high solubility and high permeability?
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What defines a drug as 'poorly water soluble' according to the BCS?
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Which factor limits absorption for Class II drugs in the BCS classification?
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In the context of drug delivery, what do poorly soluble drugs pose significant problems for?
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Which formulation method is most relevant for enhancing the solubility of poorly soluble drugs?
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What factor was found to be important for the absorption of the micronised drug in the Steroid Oral BA study in rats?
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In the BA study of lipophilic pro-drugs of phenytoin in rats after gastric administration, which factor led to a 4-fold increase in bioavailability compared to the solution of phenytoin sodium?
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What type of formulation was used for preparing lipid nanoparticles for various lipophilic drugs as mentioned in the text?
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In the BA study of the antimalarial amine in beagle dogs, which formulation resulted in a 4-fold increase in bioavailability compared to the standard capsule?
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What is the primary concern for Class II drugs in the Biopharmaceutics Classification System (BCS)?
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In the context of drug delivery, what factor is critical for poorly water soluble drugs according to the BCS?
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Which drug class poses significant problems for oral drug delivery according to the BCS?
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What percentage of new drugs are classified as poorly soluble based on the therapeutic area?
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Which factor leads to absorption limitation for Class I drugs in the BCS classification?
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What defines a drug as 'poorly water soluble' according to the BCS?
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Study Notes
Biopharmaceutics Classification System (BCS)
- The BCS is based on solubility and permeability.
- Class I drugs have high solubility and high permeability.
Drug Solubility
- A drug is defined as 'poorly water soluble' if the highest dose strength is not soluble in 250 mL or less of aqueous media over the pH range of 1.0 to 7.5.
- Poorly soluble drugs pose significant problems for oral drug delivery.
Class II Drugs
- Have low solubility and high permeability.
- Absorption is limited by solubility.
Class I Drugs
- Absorption is limited by permeability.
Drug Delivery Formulations
- Lipid nanoparticles are used for preparing various lipophilic drugs.
- Micronization is used for enhancing the absorption of poorly soluble drugs.
- Poorly soluble drugs require special formulation methods to enhance solubility.
Bioavailability Studies
- In the Steroid Oral BA study in rats, micromization was found to be important for the absorption of the drug.
- In the BA study of lipophilic pro-drugs of phenytoin in rats, a 4-fold increase in bioavailability was observed when the drug was given in a self-emulsifying drug delivery system (SEDDS) compared to the solution of phenytoin sodium.
- In the BA study of the antimalarial amine in beagle dogs, a 4-fold increase in bioavailability was observed when the drug was given in a lipid nanoparticle formulation compared to the standard capsule.
Drug Development Statistics
- Approximately 40% of new drugs are classified as poorly soluble based on the therapeutic area.
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