Term
| Types of Solid Dosage Forms |
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Definition
| Powders, Tablets, Capsules, Lozenges |
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Term
| Types of Common Liquid Dosage Forms |
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Definition
| Solution, Elixir, Syrup, Suspension, Emulsion |
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Term
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Definition
| dissolve in soft foods such as apple sauce, i.e. antacids and laxative powders |
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Term
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Definition
| bulk powder, typically contains a soap or detergent, mild abrasive and anticariogenic agent |
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Term
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Definition
| What mean people use to even out their complexion. Just kidding. Completely soluble, dissolve in water, commonly used for vaginal use. |
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Term
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Definition
| Fine powders introduced into body cavities such as the throat using a poweder blower (aeroinhaler) |
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Term
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Definition
| Powder such an antibiotic mixed in water |
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Term
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Definition
| contain sodium bicarbonate and citric acid or sodium biphostphate, in water, carbon dioxide is released, masking bitter medications |
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Term
| Advantages of Powders and Granules |
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Definition
Solids are more stable
Convenient to dispense drugs with a large dose
Powders have faster dissolution than tablets/capsules
Flexible in compounding solids |
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Term
| Disadvantages of Powders/Granules |
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Definition
Less convenient for patients to carry
hard to mask bad taste
not useful for administering low dosages of powerful drugs
Not suitable for drugs that are deactivated in the stomach |
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Term
| Multiple Compressed Tablets |
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Definition
| multi-layered tablet or tablet within a tablet |
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Term
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Definition
| pass through stomach, dissolve in intestine. |
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Term
| Buccal/Sublingual Tablets |
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Definition
| small and flat, placed under tongue |
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Term
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Definition
| Does not contain disintigrant |
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Term
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Definition
| Powders dampened by high alcohol solutions, molded, and dried. |
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Term
| Advantages of Compressed Tablets |
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Definition
Accurate dosages are simple to give
Easy bulk transport
More stable than liquids
Release rate of drug can be tailored
Quick Mass Production
Versatile |
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Term
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Definition
Hard Gelatin Capsule - Used 10X as much as Soft
Soft Gelatine Capsules |
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Term
| Advantages of Hard Gelatin Capsules |
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Definition
Better bioavalibilty than tablets
Flexibility in formulation in comparison to tablets
Bead-type can be filled w/o problems associated with compression
Ideal for clinical trials. |
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Term
| Disadvantages of Hard Gelatin Capsules |
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Definition
Number of shell suppliers is limited
Filling is slower than compression
Generally more costly
Not good for highly soluble salts, rapid release causes gastric *issues*
Can be lodged in the esophogus |
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Term
| Advantages of Soft Gelatin Capsules |
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Definition
Liquid fill is metered, highly reproduceable
higher degree of homogeneity
RApid release of liquid may lead to better bioavalibility
Hermetically sealed
Wide variety of sizes and shapes |
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Term
| Disadvantages of Soft Gelatin Capsules |
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Definition
Limited number of companies
More expensive than tablets
Higher risk of interactions between drug and shell
Drug might migrate to shell |
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Term
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Definition
| Solution: one-phase system with two or more components, Elixir: one phase, three or more components, one of which must be alcohol, Immulsion: A two-phased system with at least three components, oil, water and emulsifying agent, Suspension: two phase system, a dispersion of insoluble drug particles , Syrup: One-phase, three or more components, two of which are water and sweetener |
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Term
| Advantages of Oral Liquids |
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Definition
| Homogenous distribution of active agent, Active agent does not need to undergo dissolution, Dose can be adjusted by changing volume, easy to swallow, negate risks present in other drug forms. |
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Term
| Disadvantages of Oral Liquids |
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Definition
| things in solution more likely to degrade/hydrolize, shorter shelf life, some things taste or smell bad in solution, heavier, need temperature specific storage, pouring/measuring problematic for some, germs looove them. |
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Term
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Definition
| Water, Alcohol, Propylene Glycol, Polyethylene Glycol 400, Glycerine |
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Term
| Alcohol limit for children under 6 |
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Definition
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Term
| Alcohol Limit for children 6-12 |
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Definition
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Term
| Alcohol limit for children 12 and older |
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Definition
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Term
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Definition
| Benzoic Acids, sorbic acid, butyl parabens |
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Term
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Definition
| ascorbic acid, sodium metabisulfate, alpha-tocopheral, butylated hydroxytoluene |
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Term
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Definition
| Basically non-existant. Some laws banned poisons from the market place, but these were easily evaded. |
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Term
| What year was the national formulary established? |
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Definition
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Term
| Drug Regulation 1880s-1906 |
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Definition
| The era of patent medicines, like Vin Marini, which was laced with cocaine and opiates. |
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Term
| What year was the poorly enforced Pure Food and Drug Act passed? |
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Definition
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Term
| What triggered the Food, Drug and Cosmetic Act of 1938? |
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Definition
| A large number of kidney-failure deaths (110) caused by the drug called Elixir Of Sulfanilamide |
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Term
| Food, Drug and Cosmetic Act resulted in: |
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Definition
New drugs to be shown safe before marketing
No longer had to prove intent
Extended control to cosmetic and theraputic devices
Provided safe-tolerance levels be set for unavoidable poisonous substances
Factory Inspections
Added court injunctions to possible consequences |
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Term
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Definition
| A mild sedative and anti-nausea drug formulated for pregnant women that ended up causing really horrible birth defects |
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Term
| Kefauver-Harris Amendment |
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Definition
| Resulting from the thalidomide disaster, this amendment safety and efficacy testing, and placed emphasis on pre-clinical testing of drugs so EVERYONE COULD HAVE ARMS. |
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Term
| When did the modern era of drug regulation start? |
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Definition
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Term
| What are the steps of the drug approval process? |
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Definition
| A. Pre-Clinical Research B. Formulation Development C. Investigation New Drug Application D. Clinical Trials E. New Drug Application F. Drug Review G. The FDA review team H. Decision Making in the Review Process I. Post Marketing Surveillance. |
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Term
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Definition
| In-vitro animal models, LD50 Data, NOEL |
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Term
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Definition
| 70% of drugs that were not approved were not approved due, in part, to chemistry. Second step of drug approval process. |
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Term
| What are the three types of Investigational New Drug Application? |
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Definition
| Commercial (most common), Single Investigator, Emergency/Compassionate |
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Term
| Phase 1 of Clinical Trials |
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Definition
| Involve administering the drug to a small (20-100) number of healthy volunteers. Dosage and side effects are evaluated. |
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Term
| Phase II of Clinical Trials |
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Definition
| Determines patients' responses in "proof of concept" studies. Usually several hundred participants who have the disease. |
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Term
| Phase III of Clinical Trials |
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Definition
| Several hundred to thousands of participants, coordinated with the FDA |
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Term
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Definition
| standard review, other treatments available |
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Term
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Definition
| priority review, therapeutic gain, new mechanism of action |
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Term
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Definition
| New drug, not available to US market |
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Term
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Definition
| Derivative of active moiety approved in the US, (Salt, ester, etc.) |
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Term
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Definition
| New formulation of an approved drug |
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Term
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Definition
| new combination of drug with additional drug |
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Term
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Definition
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Term
| The Three Possible Outcomes of Drug Review: |
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Definition
| 1.) Drug approved for marketing 2.) Drug is approved, but additional information is needed. 3.) Drug is not approved because of major deficiencies |
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Term
| The Three Possible Outcomes of Drug Review: |
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Definition
| 1.) Drug approved for marketing 2.) Drug is approved, but additional information is needed. 3.) Drug is not approved because of major deficiencies |
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Term
| Types of Chemical Bonding |
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Definition
Primary Bonding
Secondary Bonding |
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Term
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Definition
| Covalent Bond and Ionic Bond |
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Term
| Types of Secondary Bonding |
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Definition
| Van der Walls forces, Hydrogen bonding, ion-dipole, ion-induced diople |
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Term
| Types of Van der Waals Forces |
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Definition
| Dipole-Dipole (Keesam), Dipole-induced Dipole (Debye), Induced dipole-induced dibole (London or Dispersion Forces) |
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Term
| Which is the strongest of the Van der waals Forces? |
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Definition
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Term
| What is an example of an Ion-Dipole Interaction ? |
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Definition
| The transition of a salt to an anion and cation |
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Term
| What is an example of an Ion-Induced Dipole? |
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Definition
| The unification of KI and I2 to make KI3 (iodine complex) |
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