Module 5

100問 • 1年前

問題一覧

The discipline that includes manufacturing development marketing and distribution of drug products including quality assurance of these activities.

Industrial pharmacy

This refers to the specific homogenous quantity of a drug or in case of drug produced according to single manufacturing order during the same cycle of manufacture.

Batch

Which of the following refers to the list of test references which are of critical quality standards for purity and safety of pharmaceutical products?

Specifications

Good Manufacturing Practice (GMP) as part of quality assurance simply means:

It is all about getting things right along the line

The ideal filler should fulfill a series of requirements, such as: I. Chemically inert II. Biocompatible III. Inexpensive IV. Hygroscopic

I, II, III

Determine the category of excipient to which lactose, cellulose, kaolin, mannitol belong.

Diluents

Determine the category of excipient to which glycerin, sorbitol, and glycerol belong to.

Humectant

Function of excipients used in tablet formulations: I. Binders promote granulation during the wet granulation process. II. Glidants help promote the flow of the tablet granulation during manufacture. III. Lubricants help the patient swallow the tablets

I, II, III

This excipient helps improve the flowability of the powder.

Glidant

Determine the function of the demulcents in Hydroxypropyl Methylcellulose Ophthalmic Solution which is used as a wetting solution for contact lenses.

Decrease the irritating effect of the lens on the cornea

Select the technique for solving flavoring problems, that involves formation of an insoluble compound with the offending drug; or increasing the viscosity fluids to limit contact of the drug with the tongue.

Physical

Identify the technique for solving flavoring problems that involves forming a complex of the drug with ion exchange resins or complexing agents.

Chemical

Classify Glycyrrhiza as a pharmaceutical necessity.

Flavoring agent

Odd man out:

Vibration Mill

Select the method of preparing powders that blend “potent” powders with a large amount of diluent.

Geometric dilution

Select the method of preparing powders that consist of enclosing the powder in a large container, which rotates and mixes the powder ingredients.

Tumbling

Determine the effect of underwetting to resulting granules.

Granules will be soft

What property of a drug product on which drug absorption and physiologic availability are largely dependent?

Tablet dissolution

Which of the following is established when pharmaceutical equivalents display comparable bioavailabilities when studied under similar experimental conditions?

Drugs are bioequivalent

What stage of the sugar-coating process is the most critical because it has the greatest impact on the FINAL visual effect, and involves the multiple application of syrup solutions containing appropriate coloring materials?

Color Coating

What is the moisture content of hard gelatin capsules?

13% – 16%

What manufacturing method uses a system of rotary dies but is unique, in that it is the only machine that can successfully fill dry powder into a soft gelatin capsule?

Accogel/Stern Process

HLB System: I. Also known as the Griffin’s method II. Hydrophilic agents have lower HLB number III. W/O Emulsifying Agent ranges from 4-6

I, III

What theory of emulsification proposes that the emulsifier forms an interface between the oil and water, surrounding the droplets of the internal phase as a “thin layer of film” adsorbed on the surface of the drops?

Interfacial Film Theory

Which of the following represents the index of the protective power of colloids?

Zsigmondy

All of the following characterizes flocculated suspension EXCEPT:

Formation of compact cake when the particles eventually settle

Identify the most dependable and widely used sterilization method that uses “moist heat” which coagulates cellular proteins of microorganism; parenteral, or injectable drug products are sterilized by this product.

Steam Sterilization

Which of the following substances can sterilize?

Ethylene oxide

Which of the following parameters should be considered when storing medications? I. Temperature II. Air Velocity III. Particle count IV. Relative Humidity

I and IV

In compounding extemporaneous preparations, the beyond-use date per USP guideline for “water-containing oral preparations” (when stored at cold temperatures), is ________.

No longer than 14 days

Which of the following is not considered as a primary packaging component?

Desiccant

Identify cosmetics which are regulated as drugs

Lip balms, Mouthwashes, Antiperspirant, Diaper Ointments

All of the following are USP tests to ensure the quality of drug products in tablet form EXCEPT:

Hardness and Friability

USP content uniformity test for tablets is used to ensure which quality?

Potency

Quality Assessment tools for non-sterile dosage forms specific for Suppositories, Troches, and Lollipops include: I. Weight and Weight variations II. Color of preparation III. Clarity IV. Appearance and feel

I, II, III, IV

How is a powder composed of particles that all pass through a No. 40 sieve, and not more than 40% pass through a No. 80 sieve?

Moderately coarse

All are advantages of Granules over Powders EXCEPT:

Less likely to cake or harden upon standing compared to powders

Analyze and select the basic product formulation for a tablet.

Active ingredient, Diluent/Filler, Binder, Disintegrant, Lubricant

Levigation: I. Commonly used in large-scale preparation of ointments and suspensions II. A paste is formed by combining the powder and a small amount of liquid (the levigating agent) in which the powder is insoluble III. Castor oil and glycerin are commonly used levigating agent IV. A figure 8 track is commonly used to incorporate the materials

II, IV

Classify the BCS compound that are of low solubility and high permeability, such that their bioavailability is limited by their solvation rate.

BCS Class II

This is a solid dosage form in which one or more APIs are dispersed in a suitable base and molded or otherwise formed into a suitable shape for insertion into the rectum to provide local or systemic effect.

Suppositories

Anhydrous Lanolin

Absorption base

Hydrophilic Ointment

Emulsion base (w/o type)

White Petrolatum

Hydrocarbon base

Tragacanth Jelly and Pectin Paste belong to what class of gel?

Hydrogel

Aluminum stearate with heavy mineral oil gel belongs to what class of gel?

Organogel

Imbibition

Taking up of a certain amount of liquid without a measurable increase in volume

This suppository base is composed of triglycerides of saturated fatty acids C12–C18 with varied portions of the corresponding partial glycerides.

Witepsol

Glycerogelatins are plastic masses containing:

Gelatin (15%), Glycerin (40%), Water (35%), and an added medicinal substance (10%)

All of the following are components of vaginal inserts: I. Filler II. Disintegrating agent III. Tablet lubricant IV. Dispersing agent

I, II, III, IV

Elixirs compared with syrups are:

Less effective in masking taste

Emulsion:

Liquid-liquid

Select the category of emulsifiers or stabilizers that are used primarily as thickening agents and stabilizers for oil- in-water emulsions of certain lotions and ointments for external use.

High molecular weight alcohols

Classify Pectin as an emulsifying agent.

High molecular weight alcohols

Flexible Colloidion: I. Flexible collodion is prepared by adding 3% castor oil to collodion II. Flexible collodion is prepared by adding 3% camphor to collodion III. The castor oil makes the product waterproof IV. The camphor makes the product waterproof

I, IV

Undesirable quality of a suspension:

Suspended particles settle rapidly

These are pressurized dosage forms that, upon actuation, emit a fine dispersion of liquid and/or solid materials containing one or more active ingredients in a gaseous medium.

Aerosol

The USP currently recognizes these categories of injections EXCEPT?

Sterile Injection

Treated Soda Lime Glass

Type II

Soda Lime Glass

Type III

This is a part of the TDDS system in which it is used to store and release the drug at the skin site.

Drug Reservoir

This part of the aerosol valve assembly is placed snugly with the stem and prevents “leakage” of the formulation when the valve is closed.

Gasket

This part of the aerosol valve assembly is attached to the aerosol can or container and holds the valve in place.

Mounting cup

Select the intermolecular force that accounts for the unusual properties of water such as its “high dielectric” constant, abnormally low vapor pressure, and high boiling point.

Hydrogen bonds

Select the intermolecular force on which attractive forces are necessary for molecules to cohere, whereas repulsive forces act to prevent the molecules from interpenetrating and annihilating each other.

Repulsive and attractive forces

Iodoform:

Hexagonal

This is the diameter of a circle with the same area as that of the particle observed “perpendicular” to the surface on which the “particle rests.”

Projected Area diameter

This is the ratio of the void volume to the bulk volume of the powder.

Porosity

Identify the property which is used to determine the molecular weight of colloids.

Light scattering

This is the solvent that is capable of “accepting” protons from the solute.

Protophilic

Micelle:

Association colloids

What method of “adjusting tonicity” and pH involves the addition of sodium chloride or some other substance to the solution of the drug to lower the freezing point of the solution to -0.52°C and thus make it isotonic with body fluids?

Class I

Class I method: I. Cryoscopic method II. White–Vincent method III. Sprowls method IV. Sodium chloride equivalent method

I, IV

What pH range is Nonionic surfactant effective?

pH 3 - 10

Select the Newtonian liquids.

Olive Oil, Chloroform

Select the Non-newtonian liquids.

Tobramycin, Chloramphenicol Palmitate Suspension

Which of the following viscometers are used in Newtonian liquids ONLY?

Ostwald Viscometer

Ostwald viscometer

Capillary

EDTA

Metal Ion Complex

Cyclodextrin

Occlusion Compound

Which of the following systems is referred to as shear “thickening?”

Dilatant

Determine the contact angle exhibited by complete wetting.

0°

Arrange the surfactants in order from the most effective to the least effective antimicrobial activity. 1. Soap 2. Anionic detergent 3. Cationic detergent

3, 2, 1

Involves detection, assessment, documentation, and reporting of Adverse Events or Adverse Drug Reactions

Pharmacovigilance

Which among the following belong to Category B Establishment?

Fourth, fifth and sixth class municipal health units

What law is violated when a Category B establishment was found selling prescription and non-prescription drugs.

RA 10918

The board may, upon petition, reinstate, or reissue a revoke COR after the expiration of _____ from the date of its revocation.

2 years

An applicant who failed in the licensure examination for the _______ time shall not be allowed to take the next succeeding examinations without having undertaken a refresher program in a duly accredited institution

Third

Select the components of an erroneous prescription.

When the generic name is enclosed within a parenthesis, and brand name is NOT

Select the components of an impossible prescription

When the brand name and generic name are NOT legible

What is meant by “Refilling of a Prescription”?

Dispensing the remaining balance of medicines ordered in the prescription

Which statements BEST describes RA 11223?

Every Filipino citizen shall be automatically included into the National Health Insurance Program, hereinafter referred to as the Program.

Identify the components of the “Essential Health Benefit Package” in the Universal Health Care Law

Primary care, medicines, diagnostic and laboratory tests, preventive, curative, and rehabilitative services

Identify the law violated when Flower Pharmacy was found selling counterfeit medicines.

RA 8203

All of the following parties are liable for RA 8203 EXCEPT:

The person who possess counterfeit drugs with receipt

Identify the S-license issued to retailers of dangerous drugs and their preparations.

S-3

Identify the S-license issued to wholesalers/distributors of dangerous drugs and their preparations.

S-4

The Expanded Senior Citizens Act of 2010:

RA 9994

An Act Providing for the Mandatory Philhealth Coverage for All Senior Citizens:

RA 10645

100

RA 8203

Special Law on Counterfeit Drugs

Module 2 Part 1

ユーザ名非公開 · 100問 · 1年前

Module 2 Part 1