Pharmaceutical Drug Delivery Systems

Questions and Answers

What does chemical stability ensure in a drug product?

The therapeutic effect of the drug product changes over time.

The product remains effective against microbial growth.

Each active ingredient retains its chemical integrity and potency. (correct)

The drug product will maintain its physical appearance.

Which factor does NOT affect the stability of a pharmaceutical product?

Environmental conditions during storage.

The color of the packaging. (correct)

The dosage form of the product.

The manufacturing process used.

What type of stability is indicated by the retention of sterility or resistance to microbial growth?

Physical stability

Chemical stability

Microbiological stability (correct)

Toxicological stability

Physical stability of a drug product includes retention of which of the following?

Original physical properties Signup and view all the answers

Which of these conditions would most likely decrease the chemical stability of a drug?

Exposure to excessive heat. Signup and view all the answers

Which of the following statements is true regarding toxicological stability?

No significant increase in toxicity occurs. Signup and view all the answers

What two forms of stability evaluations are classically separated in pharmaceutical studies?

Chemical and physical stability. Signup and view all the answers

Which aspect of drug stability addresses the maintenance of effectiveness of antimicrobial agents?

Microbiological stability Signup and view all the answers

What is considered an acceptable maximum weight loss during the tablet friability test?

1% Signup and view all the answers

What is the primary purpose of conducting a dissolution test?

To estimate bioavailability Signup and view all the answers

Which of the following best describes the relationship between dissolution conditions and bioavailability?

Dissolution conditions must be established clinically to relate to bioavailability. Signup and view all the answers

Why should the same instrument be used in friability tests throughout a study?

Different instruments can yield inconsistent results. Signup and view all the answers

What could cracks, mottling, or tackiness of tablet coating indicate?

Evidence of instability Signup and view all the answers

Which method is primarily used to follow color stability of tablets?

Colorimeter or reflectometer Signup and view all the answers

What temperature is typically used for dissolution tests?

37°C Signup and view all the answers

What test has disintegration been relegated to during the development of pharmaceuticals?

In-process test Signup and view all the answers

What effect does a temperature increase have on the rate of oxidation?

It accelerates the rate of oxidation. Signup and view all the answers

Which of the following molecular structures is most likely to oxidize?

Hydroxyl groups bonded to aromatic rings Signup and view all the answers

Which condition is likely to catalyze oxidation processes?

pH values higher than optimum Signup and view all the answers

What happens to the therapeutic activity of products following oxidation?

It usually lacks therapeutic activity. Signup and view all the answers

How can the stabilization of penicillin be affected by copper ions?

As little as 0.2 mg of copper ion per liter considerably reduces stability. Signup and view all the answers

Which of the following is a recommended method to minimize oxidation in formulations?

Working in a nitrogen atmosphere Signup and view all the answers

What role do heavy metal ions play in oxidative reactions?

They can catalyze oxidation reactions. Signup and view all the answers

Which agents are commonly added to water to help reduce oxidation due to heavy metals?

Chelating agents Signup and view all the answers

What characterizes a Type 1 error in the context of expiration dating?

The product is labeled with an expiration date that is too early. Signup and view all the answers

Which statement is true regarding the reasons for studying physical stability in pharmaceuticals?

To ensure the drug product remains visually appealing over time. Signup and view all the answers

What is a potential consequence of a physical stability failure in a drug product?

The active ingredient may not be released properly. Signup and view all the answers

What is required from manufacturers regarding the prediction of shelf life?

They should include the statistical approach and error types. Signup and view all the answers

Which statement regarding simultaneous chemical stability failures is correct?

It is possible, although remote, for both types to occur in the same product. Signup and view all the answers

What is a possible outcome of a Type 2 error in pharmaceutical stability studies?

A degradation product is not detected in time. Signup and view all the answers

Which of the following describes an intrinsic part of the statistical methodology for stability studies?

The definition of acceptable levels for change within the product. Signup and view all the answers

What may indicate a failure related to appearance in drug formulation?

Loss of elegant appearance but not effectiveness. Signup and view all the answers

What is a key feature of a transdermal patch regarding its adhesive?

It must adhere well to both the backing and the patient's skin. Signup and view all the answers

Which test is NOT typically included in the stability assessment for metered-dose aerosol drug products?

Drug release per USP Signup and view all the answers

For which type of inhalation product is it crucial to ensure the emitted particle size is appropriate for lung deposition?

Dry-powdered inhalation products Signup and view all the answers

Which factor does NOT influence the shelf life of metered-dose aerosol drug products?

Particle size of the drug Signup and view all the answers

What is essential for the appearance of a transdermal patch over its shelf life?

It should maintain pharmaceutical elegance. Signup and view all the answers

What is a potential stability concern when using metered-dose inhalation products?

Leachable from the delivery device Signup and view all the answers

What must be verified in the stability testing of dry-powdered inhalation products?

Emitted dose and particle size distribution Signup and view all the answers

What is a key characteristic of a nasal inhalation product delivery system?

It must be integrated with the active drug. Signup and view all the answers

Study Notes

Transdermal Patches

Must deliver drugs as labeled and adhere properly to backing and skin.
Should exhibit pharmaceutical elegance throughout shelf life.
Release liner must peel easily with minimal adhesive transfer; adhesive should not ooze from patch sides.
Stability tests include: appearance, assay, impurities, drug release (per USP), and backing peel force.

Metered-Dose Aerosols

Comprise an aerosol can with propellant, drug, and a mouthpiece for drug delivery.
Drug contact components may allow plasticizer leach into the propellant.
Stability tests involve: appearance, assay, impurities, plume geometry, emitted dose, particle size distribution, and number of doses.
Shelf life may vary based on storage orientation; typically tested upright.

Dry-Powdered Inhalation Products

Consist of drug and excipients in dry powdered form; delivery can be a separate device or integrated.
Must reproducibly deliver a specific drug amount at an optimal particle size for lung deposition.
Stability tests include: appearance, assay, impurities, emitted dose, particle size distribution, and water content.

Nasal Inhalation Products

Deliver drug with excipients; the delivery system can be separate or integrated.
Assigned expiration dates are based on stability study results.

Types of Stability

Chemical Stability: Active ingredients maintain integrity and potency within specified limits.
Physical Stability: Original physical properties (appearance, palatability, dissolution) are retained.
Microbiological Stability: Sterility and antimicrobial efficacy are preserved according to requirements.
Therapeutic Stability: Therapeutic effect remains unchanged.
Toxicological Stability: No significant increase in toxicity over time occurs.

Factors Affecting Stability

Intrinsic stability of active ingredient(s) and interactions with inactive ingredients are critical.
Manufacturing process, dosage form, container closure system, and environmental conditions can influence stability.

Chemical failures may include a decrease in therapeutic activity or formation of toxic degradation products.
Physical failures might impact drug release or aesthetic qualities of the product.

Physical Stability Testing

Tablet friability testing assesses durability; acceptable weight loss is typically no more than 1%.
Colors are monitored using colorimeters; elevated temperatures can alter degradation mechanisms.

Dissolution and Drug Release Tests

Dissolution tests measure bioavailability; conditions are established during clinical development.
Increased temperature accelerates oxidation; storage at 0-5°C may halve oxidation rates.

Oxidative Stability

Compounds with hydroxyl groups on aromatic rings and unsaturated derivatives are prone to oxidation.
Oxidation is catalyzed by high pH, certain heavy metals, oxygen exposure, and UV light.
Antioxidants and special packaging (e.g., opaque materials) help mitigate oxidation risks.

Heavy Metal Contamination

Trace metals like copper can significantly reduce stability of certain drugs (e.g., penicillin).
Proper manufacturing practices should prevent parenteral formulations from contacting heavy metals.

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Description

This quiz explores various pharmaceutical drug delivery systems, including transdermal patches, metered-dose aerosols, and dry-powdered inhalation products. Participants will learn about the requirements for each system, stability tests, and delivery methods. Test your knowledge on the intricacies of these essential drug delivery techniques.