Term
What is Pharmaceutics? (2) |
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Definition
Pharmaceutics is the science of preparing drug products, AFTER an API (active pharmaceutical ingredient) is discovered, tested, synthesized and purified.
- The science of dosage form design |
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Term
What does Physical Pharmacy study? What is it important for? |
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Definition
Physical Pharmacy studies the Physico-chemical properties of drugs(Uses theoretical principles). It is important in the formulation of dosage forms. |
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Term
What is Pharmaceutical Science? |
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Definition
The APPLIED Science, which links physical, chemical, and biologic sciences |
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Term
What is a drug ? What is a drug Product ?? |
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Definition
*A drug is an agent used in diagnosis, migitation, treatment, cure, or prevention of disease in humans.
*A drug product is the finished dosage form which includes the API, and other substances in the "formulated" product |
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Term
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Definition
A dosage form is a formulated drug preparation that is administered to the patient through a certain route. |
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Term
What is formulation (of a dosage form)? |
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Definition
Formulation is the process to develop a formula for the preparation of a drug product. (a recipe almost) |
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Term
What is a Drug Delivery System? |
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Definition
A DDS is drug product or device that safely administers therapeutic agents to the body at a specific site, at a certain rate to achieve effective drug concentration. |
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Term
What is the API ? What is it's function? |
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Definition
An API is an Active Pharmaceutical Ingredient. Its function is to carry out pharmacologic activity by aiding in the diagnosis, cure, mitigation, treatment, or prevention of disease. |
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Term
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Definition
An inactive ingredient in the drug, that serves as a non-medical purpose. |
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Term
EXCIPIENTS- What do flavorants impart? What do colorants impart? Anti-oxidants/chelating agents? Preservatives? |
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Definition
-Flavor/odor -color -prevent oxidation/deterioration -protect against microbial contamination |
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Term
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Definition
A prodrug is a compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound. |
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Term
What is a polymorph? How are they made? |
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Definition
A polymorph is a substance that has more than one crystalline form with different physical properties.
Made using different temperatures, pressures, concentration, impurities, supersaturation etc. |
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Term
What is an amorphous solid? What can it be considered? |
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Definition
An Amorphous solid arranges its molecules randomly like a liquid.
It can be considered a super-cooled liquid |
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Term
In what sequence does the introduction of a drug take, using the following 4 options:
-NDA Review -Postmarketing surveillance -Preclinical Research and development -Clinical Research and development |
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Definition
1)preclinical R&D 2)Clinical R&D 3)NDA Review 4)Postmarketing surveillance. |
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Term
What chemical and physical properties are determined during preformulation? |
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Definition
Drug Solubility, Partition coefficient, dissolution rate, physical form, stability |
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Term
What are placebo's and comparator drugs? |
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Definition
A placebo/comparator drug does not contain the active ingredient, and is tested in phases II and III of a drug. |
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Term
What are single blinded, double blinded, or open label studies? |
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Definition
Single Blinded - patient doesn't know of what agent is administered
Double Blinded- Patient & Clinician are unaware what agent is administered
Open-Label - both patient and clinician are aware of drug administered. |
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