Pharmaceutics and Dosage Form Design
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Questions and Answers

Which aspect of pharmaceutics is MOST directly concerned with how a drug is absorbed, distributed, metabolized, and eliminated by the body?

  • Biopharmaceutics (correct)
  • Quality Control and Assurance
  • Stability Testing
  • Dosage Form Design

A pharmaceutical company is developing a new tablet formulation for an existing drug. Which preformulation study would be MOST critical in determining if the drug can be effectively made into a tablet?

  • Microbial growth studies
  • Taste-masking evaluations
  • Color and odor assessment
  • Particle size and powder flow properties (correct)

A drug is known to undergo significant degradation in the presence of moisture. Which excipient would be LEAST suitable for use in a tablet formulation of this drug?

  • Calcium phosphate dibasic
  • Anhydrous lactose
  • Microcrystalline cellulose (correct)
  • Magnesium stearate

A drug is intended to treat a localized skin infection. Which dosage form would be MOST appropriate to minimize systemic side effects?

<p>Topical cream (B)</p> Signup and view all the answers

Which route of administration bypasses first-pass metabolism, leading to higher bioavailability and rapid drug effect?

<p>Intravenous (C)</p> Signup and view all the answers

A pharmaceutical manufacturer discovers that a batch of tablets does not meet content uniformity specifications. Under which guidelines would this be investigated?

<p>GMP (B)</p> Signup and view all the answers

A drug is designed to release its medication over an extended period after oral administration. What type of formulation is this?

<p>Extended-release (C)</p> Signup and view all the answers

Which factor is LEAST likely to affect the stability of a drug product?

<p>Patient age (D)</p> Signup and view all the answers

A generic drug manufacturer must demonstrate that its product is bioequivalent to the reference listed drug. Which application is required for this approval?

<p>ANDA (D)</p> Signup and view all the answers

During the scale-up of a tablet manufacturing process, what is the primary goal of process validation?

<p>Confirming consistent product quality (A)</p> Signup and view all the answers

What is the MOST important consideration when designing a controlled-release oral dosage form?

<p>The drug's solubility and stability within the GI tract (D)</p> Signup and view all the answers

A pharmacist notices a change in the appearance of a medication, such as a change in color or the formation of a precipitate. What type of pharmaceutics study can help determine if the medication is still safe and effective to use?

<p>Stability testing (D)</p> Signup and view all the answers

What is the appropriate term to describe the rate and extent to which an active drug ingredient is absorbed from a drug product and becomes available at the site of action?

<p>Bioavailability (B)</p> Signup and view all the answers

Which of the following is NOT a primary goal of drug targeting?

<p>Increasing the drug's volume of distribution (D)</p> Signup and view all the answers

If a drug is poorly soluble in water, which formulation strategy might be employed to improve its oral bioavailability?

<p>Reducing the particle size of the drug (A)</p> Signup and view all the answers

Flashcards

Pharmaceutics

The science of turning drugs into safe and effective medications.

Preformulation Studies

Characterizing drug & excipient properties for stable dosage forms.

Formulation Development

Combining APIs and excipients into a suitable form for administration.

Dosage Form Design

Selecting appropriate forms like tablets or injections.

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Manufacturing

Large-scale production ensuring consistent quality.

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Biopharmaceutics

How drugs are absorbed, distributed, metabolized, and excreted.

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Bioavailability

Rate and extent a drug becomes available at the site of action.

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Good Manufacturing Practice (GMP)

Drugs are consistently produced and controlled

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Pharmacokinetics

How a drug is absorbed, distributed, metabolized, and eliminated.

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Pharmacodynamics

Biochemical and physiological effects of drugs and their mechanisms

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Parenteral Route

Route bypassing first-pass metabolism for rapid delivery.

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Immediate-Release Formulation

Releases drug immediately after administration.

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Extended-Release Formulation

Releases drug over a prolonged period.

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Stability Testing

Assessment of drug products under storage conditions

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Dissolution rate

Rate at which a drug dissolves.

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Description

Pharmaceutics is the science of turning drugs into safe and effective medications through dosage form design. Key areas include drug design, preformulation studies, and formulation development. It focuses on the manufacture, stability, and effectiveness of pharmaceutical dosage forms.

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