TOPIC QUIZ: Manufacturing Pharmacy

What law or issuance contains the requirements for Good Manufacturing Practice applied to premises, equipment, personnel, products and warehouse?

DOH Administrative order

Identify the glass container that is composed of relatively high proportions of sodium oxide and calcium oxide; has a relatively lower concentration of migratory oxides; considered to be of relatively good chemicals resistance for only one use; and suitable for solutions that are buffered and have a pH 7 or are not reactive with the glass

Type II

Identify the unit operation that includes evaluation of the drug for uniformity, stability, and other factors, followed by the development of an appropriate drug delivery system.

Formulation

Analyze and select the basic product formulation for a tablet

Active ingredient, lubricant, binder, disintegrant, filler

Determine the role of lactose, cellulose, kaolin, mannitol in a tablet formation

Diluents

This is a tablet formulation for CT Acetaminophen prepared by the wet granulation method. One tablet contains

Acetaminophen - 300mg

Polyvinylpyrrolidone - 22.5 mg

Lactose - 61.75 mg

Alcohol (200 proof) - 4.5 ml

Stearic acid - 9.0mg

Talc - 13.5mg

Corn starch - 43.25mg

To make 10,000 tablets, calculate the amount of Acetaminophen to be weighed (in grams).

3,000 g

Determine the role of corn, potato starch, gums, and algins in a tablet formulation.

Disintegrants

Determine the role of aspartame in tablet formation.

Sweetening agent

In a product formulation, determine the excipient which provides bulks and enables accurate dosing of potent ingredients

Diluent

Classify ethyl cellulose as a pharmaceutical excipient.

Tablet binder

Choose the coloring principles that are used as colors for food and cosmetics and are NOT obtained from a biological source.

Nitroso-dyes

Determine the effect of over wetting to resulting granules

Granules will be hard

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

Chemical

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

Physical

Classify Glycyrrhiza as a pharmaceutical necessity.

Flavoring agent

This defect occurs as a split in the tablet anywhere except the top; it often happens due to aver compression of the tablet

Lamination

This occurs when the granules stick to the design embedded in the punch tip such as in the lettering or logo

Picking

The key to controlling this defect is maintaining the compression force of the tablet

Hardness

This refers to the tendency for a tablet to chip, crumble or break following compression

Cracking

This defect is a result of partial spray during off because of over wetting causing soft coating to rub.

Film cracking type II

A fracture occurs at the top tablet and the top separates itself from the body of the solid tablet

Capping

Coating cracks due to thermal expansion of tablet cores and lack of film flexibility caused by over drying

Film cracking type I

This is often associated with exposure of tablet cores to coating process conditions rather than a direct effect of the applied coating

Delayed dissolution

Coating cracks due to core swelling caused by excessive moisture uptake into tablet cores during application of coating.

Film cracking type II

This defect occurs when the granules of a formulation become stuck to the face of the press punch

Sticking

Identify the coating defect, which result in a film that is rough and nonglossy

Orange peel effect

Determine the important property of a drug product on which drug absorption and physiologic availability are largely dependent.

Tablet dissolution

Dosage form not tested for rheology

Tablet coatings

Mechanism of mercurial as preservative

Denaturation of enzymes by combining with thiol (-SH) groups

Mechanism of alcohol as preservative

Lytic and denaturation action on membrane

Sodium bisulfite

Antioxidant

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

Serve as decongestant when lacrimation is inadequate

Preservatives interfere with microbial growth and metabolism through one or more of these mechanism, EXCEPT:

Reversible protein precipitation

Select the principal category to which clay, silica gel, colloids, metals, activated charcoal, activated alumina belong.

Adsorbent

Select the appropriate remedy to reduce or prevent flocculation of pharmaceutical suspensions.

Add an amount of aluminum chloride that will bring about a sedimentation volume equal to 1

Find the suspending agent which is not obtained from a natural source.

Methyl cellulose

Classify acacia as a pharmaceutical excipient.

Suspending agents

Effect of protein as a suspending agent

Suspension becomes fluid and more fluid on standing

Classify the emulsifying agent pectin, agar, tragacanth

Carbohydrate materials

Classify the emulsifying agent: colloidal clays, bentonite

Finely divided solids

Classify the emulsifying agent: glycerylmonostearate

High molecular weight alcohols

Classify the emulsifying agent: gelatin

Protein substances

Classify the emulsifying agent: chondrus, acacia

Carbohydrate materials

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

Identify the pharmaceutical Ingredient that prevents drying of preparations due to its ability to retain moisture

Humectant

Select the principal category to which Glycerin, honey, glucose syrup, egg yolk, sugar alcohols belong.

Humectant

Which will not flocculate emulsions?

lubricant

Dosage form with instabilities such as flocculation, creaming

Emulsions

Non-ionic surfactants are effective over pH range of to

3 to 10

Which of the following is not a non-ionic surfactant?

Betaine and Lecithin

Evaluate which sterilization method is the most dependable and widely used sterilization method uses moist heat, which coagulates cellular proteins of microorganisms, parenterals or injectable products (in their containers) are sterilized by this method.

Steam sterilization

Analyze which sterilization method allows the sterilization of packaged finished products that are ready for shipment because sterilizing material permeates sealed plastic films and cartons.

Ionizing radiation