70 Questions
What is the primary factor influencing the design of the optimum dosage form for a drug?
Dissolution and absorption of the active pharmaceutical ingredient (API)
What is the purpose of preformulation studies in drug development?
Determining characteristics of active substances and excipients
In which phase of drug development do safety, efficacy, and monitoring of adverse reactions take place?
Phase III
What process occurs in the pre-discovery stage of drug development?
Literature searches and disease understanding
What percentage of drugs usually move from Phase II to Phase III of drug development?
25% to 30%
Which phase of drug development focuses on determining the safety and dosage of the drug?
Phase I
What is the purpose of pharmacovigilance in drug development?
Reporting adverse drug reactions
What is the key focus of Phase II in drug development?
Monitoring safety and efficacy
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
What is the main purpose of in-vivo screening in drug development?
To determine the effective dose of the drug
What needs to be submitted first before proceeding to clinical trials?
Investigational New Drug Application
What was given the project code 7901 at the University of the Philippines - College of Pharmacy?
Clinical trial plan
What was lacking in local pharmaceutical companies regarding herbal medicines manufacturing according to the text?
Manufacturing herbal medicines
What process must be completed before proceeding to clinical trials?
Pre-clinical test results submission
Why is amorphous insulin used for rapid onset effects?
It has a disorderly manner
Which type of insulin is used for longer duration of action?
Crystalline insulin
What defines amorphous solids?
Disorderly manner
Why is differentiation between crystalline and amorphous solids important for insulin?
To ensure a correct dose and patient safety
Why should we ensure the stability of a drug or drug product according to the text?
To care for patient's health and safety
What role do polymers play in pharmaceutical formulations?
Act as excipients for API stability
How do crystalline insulin and amorphous insulin differ in terms of administration?
Crystalline is used for long duration, amorphous for rapid onset
Why are amorphous solids easily dissolved in water?
They have a disorderly manner
What ensures that the correct dose and no toxic substances are produced over time according to the text?
'Quality Assurance' processes
Why is it essential to know the melting points of the polymorphs of cocoa butter?
To determine the suitable formulation for dosage forms
What is the significance of cocoa butter melting at normal body temperature?
It ensures easy handling during suppository preparation
Which characteristic of different polymorphs can significantly affect drug bioavailability and stability?
Melting point
Why is the B1 polymorph of cocoa butter considered the best suppository base?
It prevents suppositories from melting in hands
What is the primary reason for using cocoa butter as a suppository base?
To enhance drug stability and absorption rate
How does knowing the melting points aid in selecting polymorphs for formulation?
It assists in determining suitable dosage form preparations
In what way can different polymorphs affect drug bioavailability?
By altering drug absorption and stability
What factor makes B1 polymorph ideal to prevent suppositories from melting in one's hands?
Its close proximity to room temperature melting point
Why is it important to add as few ingredients as possible when formulating suspensions?
To prevent incompatibility issues
In the context of pharmaceutical formulations, why is cost-effectiveness a critical factor when selecting excipients for an API?
To minimize manufacturing costs
What is the primary purpose of dissolution testing in pharmaceuticals?
To measure the rate at which a drug dissolves in any medium
How does selecting a suitable excipient for an API contribute to ensuring drug stability?
By reducing the risk of incompatibility issues
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
How does an increase in wettability of particles affect dissolution rate?
Causes a high dissolution rate
What role do bigger pores play in the dissolution process?
Facilitate easier diffusion and solubilization
How do particle size and surface area correlate with dissolution rate?
Larger surface area increases dissolution rate
Which API property directly influences dissolution rate?
pKa
How does the biological fluid system pH affect dissolution rate?
Acidic pH decreases dissolution rate
What is the main concern when dealing with saturated solutions and the solubility of APIs?
Avoiding precipitation
In pharmaceutical formulation, why is it crucial to combine oil-soluble ingredients with oil and water-soluble ingredients with water?
To prevent phase separation
What factor does not contribute to the Absolute (Intrinsic) Solubility of a drug compound?
Presence of polymorphs
Why is it important to consider intermolecular forces of attraction (IMFAs) when formulating dosage forms?
To control solubility
What term describes the point at which an API starts to precipitate due to exceeding its solubility in a solution?
Supersaturation
What is a key consideration when dealing with drug dissolution?
The partition coefficient of the drug
Why is it important to avoid precipitation of ingredients in a solution?
To ensure proper solubility of the drug
What relationship does calcium compounds exhibit between solubility and temperature?
Inverse relationship
Why is understanding the crystal form (amorphous vs crystalline) important in drug release?
To control the drug's dissolution rate
In terms of stability, why are some solutions temperature-dependent in their solubility?
To retain proper solubility under different conditions
Why is it crucial for excipients to be physiologically inert?
To enhance the stability and bioavailability of the active pharmaceutical ingredient (API).
Which property of excipients is essential to prevent microorganism contamination in pharmaceutical formulations?
Microbiological purity
How does the presence of certain excipients influence drug bioavailability?
By enhancing dissolution rate
What role do excipients play in ensuring the stability of a drug product over time?
They prevent physical changes in the drug product.
Why must excipients be compatible with the active pharmaceutical ingredient (API)?
To ensure no interference with drug bioavailability.
What is the key factor influencing the partitioning of drugs across membranes?
The drug's chemical composition
Which statement best describes the concept of polymorphism in pharmaceutical compounds?
Polymorphism involves the existence of a compound in more than one crystalline structure.
How does the presence of preservatives in emulsions relate to drug stability?
Preservatives prevent microbial attack on emulsions.
What role do weak electrolytes play in the partitioning process between two immiscible liquids?
Weak electrolytes affect the movement of molecules between phases.
Why is understanding the difference between crystalline and amorphous solids crucial for drug formulation?
It can significantly affect drug bioavailability and stability.
What is the primary purpose of providing an enteric-coated layer to a dosage form?
Protect the drug from degradation by enzymatic juices
How does solubility affect the bioavailability of a drug?
Lower solubility leads to higher bioavailability
In pharmaceutical formulations, what role do excipients play?
Control drug release rate
Which factor determines the partition coefficient of a drug between two immiscible phases?
Drug solubility
What is a key concern when determining drug stability under different conditions?
Reactions leading to degradation
Which property of excipients is essential for ensuring proper dissolution and absorption of the active pharmaceutical ingredient (API)?
Disintegrant properties
Why is it important to address concerns related to drug stability in formulation development?
To ensure drug efficacy and safety
How does partitioning affect the distribution of a drug within the body?
Affects where and how much of the drug reaches its target site
What effect does crystal form have on the dissolution rate of a drug?
Decreases dissolution rate
Test your knowledge on the melting points of different polymorphs of cocoa butter and their suitability for dosage forms. Learn about the importance of melting points in formulating emulsions. Figure out which polymorph is ideal for specific applications.
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