130 - Quiz 2

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What is the primary factor influencing the design of the optimum dosage form for a drug?

Literature searches in the pre-discovery stage

Safety and efficacy in human subjects

Preclinical research results

Dissolution and absorption of the active pharmaceutical ingredient (API) (correct)

What is the purpose of preformulation studies in drug development?

Monitoring adverse reactions in patients

Assessing short-term side effects of drugs

Conducting clinical trials on human subjects

Determining characteristics of active substances and excipients (correct)

In which phase of drug development do safety, efficacy, and monitoring of adverse reactions take place?

Phase II

Phase III (correct)

Pre-discovery stage

Phase I

What process occurs in the pre-discovery stage of drug development?

Literature searches and disease understanding Signup and view all the answers

What percentage of drugs usually move from Phase II to Phase III of drug development?

25% to 30% Signup and view all the answers

Which phase of drug development focuses on determining the safety and dosage of the drug?

Phase I Signup and view all the answers

What is the purpose of pharmacovigilance in drug development?

Reporting adverse drug reactions Signup and view all the answers

What is the key focus of Phase II in drug development?

Monitoring safety and efficacy Signup and view all the answers

What is the purpose of in-vitro screening in drug development?

To prove the chemical activity of the drug using cell lines, enzymes, and chemical tests Signup and view all the answers

What is the main purpose of in-vivo screening in drug development?

To determine the effective dose of the drug Signup and view all the answers

What needs to be submitted first before proceeding to clinical trials?

Investigational New Drug Application Signup and view all the answers

What was given the project code 7901 at the University of the Philippines - College of Pharmacy?

Clinical trial plan Signup and view all the answers

What was lacking in local pharmaceutical companies regarding herbal medicines manufacturing according to the text?

Manufacturing herbal medicines Signup and view all the answers

What process must be completed before proceeding to clinical trials?

Pre-clinical test results submission Signup and view all the answers

Why is amorphous insulin used for rapid onset effects?

It has a disorderly manner Signup and view all the answers

Which type of insulin is used for longer duration of action?

Crystalline insulin Signup and view all the answers

What defines amorphous solids?

Disorderly manner Signup and view all the answers

Why is differentiation between crystalline and amorphous solids important for insulin?

To ensure a correct dose and patient safety Signup and view all the answers

Why should we ensure the stability of a drug or drug product according to the text?

To care for patient's health and safety Signup and view all the answers

What role do polymers play in pharmaceutical formulations?

Act as excipients for API stability Signup and view all the answers

How do crystalline insulin and amorphous insulin differ in terms of administration?

Crystalline is used for long duration, amorphous for rapid onset Signup and view all the answers

Why are amorphous solids easily dissolved in water?

They have a disorderly manner Signup and view all the answers

What ensures that the correct dose and no toxic substances are produced over time according to the text?

'Quality Assurance' processes Signup and view all the answers

Why is it essential to know the melting points of the polymorphs of cocoa butter?

To determine the suitable formulation for dosage forms Signup and view all the answers

What is the significance of cocoa butter melting at normal body temperature?

It ensures easy handling during suppository preparation Signup and view all the answers

Which characteristic of different polymorphs can significantly affect drug bioavailability and stability?

Melting point Signup and view all the answers

Why is the B1 polymorph of cocoa butter considered the best suppository base?

It prevents suppositories from melting in hands Signup and view all the answers

What is the primary reason for using cocoa butter as a suppository base?

To enhance drug stability and absorption rate Signup and view all the answers

How does knowing the melting points aid in selecting polymorphs for formulation?

It assists in determining suitable dosage form preparations Signup and view all the answers

In what way can different polymorphs affect drug bioavailability?

By altering drug absorption and stability Signup and view all the answers

What factor makes B1 polymorph ideal to prevent suppositories from melting in one's hands?

Its close proximity to room temperature melting point Signup and view all the answers

Why is it important to add as few ingredients as possible when formulating suspensions?

To prevent incompatibility issues Signup and view all the answers

In the context of pharmaceutical formulations, why is cost-effectiveness a critical factor when selecting excipients for an API?

To minimize manufacturing costs Signup and view all the answers

What is the primary purpose of dissolution testing in pharmaceuticals?

To measure the rate at which a drug dissolves in any medium Signup and view all the answers

How does selecting a suitable excipient for an API contribute to ensuring drug stability?

By reducing the risk of incompatibility issues Signup and view all the answers

Why is it important to consider a solvent's ability to dissolve an API when formulating pharmaceuticals?

To ensure effective delivery and absorption of the drug Signup and view all the answers

How does an increase in wettability of particles affect dissolution rate?

Causes a high dissolution rate Signup and view all the answers

What role do bigger pores play in the dissolution process?

Facilitate easier diffusion and solubilization Signup and view all the answers

How do particle size and surface area correlate with dissolution rate?

Larger surface area increases dissolution rate Signup and view all the answers

Which API property directly influences dissolution rate?

pKa Signup and view all the answers

How does the biological fluid system pH affect dissolution rate?

Acidic pH decreases dissolution rate Signup and view all the answers

What is the main concern when dealing with saturated solutions and the solubility of APIs?

Avoiding precipitation Signup and view all the answers

In pharmaceutical formulation, why is it crucial to combine oil-soluble ingredients with oil and water-soluble ingredients with water?

To prevent phase separation Signup and view all the answers

What factor does not contribute to the Absolute (Intrinsic) Solubility of a drug compound?

Presence of polymorphs Signup and view all the answers

Why is it important to consider intermolecular forces of attraction (IMFAs) when formulating dosage forms?

To control solubility Signup and view all the answers

What term describes the point at which an API starts to precipitate due to exceeding its solubility in a solution?

Supersaturation Signup and view all the answers

What is a key consideration when dealing with drug dissolution?

The partition coefficient of the drug Signup and view all the answers

Why is it important to avoid precipitation of ingredients in a solution?

To ensure proper solubility of the drug Signup and view all the answers

What relationship does calcium compounds exhibit between solubility and temperature?

Inverse relationship Signup and view all the answers

Why is understanding the crystal form (amorphous vs crystalline) important in drug release?

To control the drug's dissolution rate Signup and view all the answers

In terms of stability, why are some solutions temperature-dependent in their solubility?

To retain proper solubility under different conditions Signup and view all the answers

Why is it crucial for excipients to be physiologically inert?

To enhance the stability and bioavailability of the active pharmaceutical ingredient (API). Signup and view all the answers

Which property of excipients is essential to prevent microorganism contamination in pharmaceutical formulations?

Microbiological purity Signup and view all the answers

How does the presence of certain excipients influence drug bioavailability?

By enhancing dissolution rate Signup and view all the answers

What role do excipients play in ensuring the stability of a drug product over time?

They prevent physical changes in the drug product. Signup and view all the answers

Why must excipients be compatible with the active pharmaceutical ingredient (API)?

To ensure no interference with drug bioavailability. Signup and view all the answers

What is the key factor influencing the partitioning of drugs across membranes?

The drug's chemical composition Signup and view all the answers

Which statement best describes the concept of polymorphism in pharmaceutical compounds?

Polymorphism involves the existence of a compound in more than one crystalline structure. Signup and view all the answers

How does the presence of preservatives in emulsions relate to drug stability?

Preservatives prevent microbial attack on emulsions. Signup and view all the answers

What role do weak electrolytes play in the partitioning process between two immiscible liquids?

Weak electrolytes affect the movement of molecules between phases. Signup and view all the answers

Why is understanding the difference between crystalline and amorphous solids crucial for drug formulation?

It can significantly affect drug bioavailability and stability. Signup and view all the answers

What is the primary purpose of providing an enteric-coated layer to a dosage form?

Protect the drug from degradation by enzymatic juices Signup and view all the answers

How does solubility affect the bioavailability of a drug?

Lower solubility leads to higher bioavailability Signup and view all the answers

In pharmaceutical formulations, what role do excipients play?

Control drug release rate Signup and view all the answers

Which factor determines the partition coefficient of a drug between two immiscible phases?

Drug solubility Signup and view all the answers

What is a key concern when determining drug stability under different conditions?

Reactions leading to degradation Signup and view all the answers

Which property of excipients is essential for ensuring proper dissolution and absorption of the active pharmaceutical ingredient (API)?

Disintegrant properties Signup and view all the answers

Why is it important to address concerns related to drug stability in formulation development?

To ensure drug efficacy and safety Signup and view all the answers

How does partitioning affect the distribution of a drug within the body?

Affects where and how much of the drug reaches its target site Signup and view all the answers

What effect does crystal form have on the dissolution rate of a drug?

Decreases dissolution rate Signup and view all the answers