Pharmaceutical Preparations Quiz

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Questions and Answers

What is one use of ethanol in pharmaceutical preparations?

Coloring agent

Thickening agent

Flavoring agent

Antimicrobial activity (correct)

Which of the following oils are considered organic solvents for oleaginous injections?

Corn oil (correct)

Glycerin

Isopropyl alcohol

Glycol

What is the ideal pH for injectable solutions?

6.0

7.4 (correct)

5.5

4.0

Which combination of flavor and color is correct for cherry flavor?

Cherry - Pink-Red Signup and view all the answers

What is a suitable masking flavor for relief of indigestion?

Mint Signup and view all the answers

Which of the following is NOT an additive flavor for oral products?

Cinnamon Signup and view all the answers

What characteristic must drinking water have to be considered acceptable in pharmaceutical preparations?

Clear, colorless, and odorless Signup and view all the answers

What is propylene glycol used as in pharmaceutical preparations?

Viscous liquid substitute for glycerin Signup and view all the answers

What is the maximum allowable amount of solid impurities in purified water, when evaporated to dryness?

1 mg per 100ml Signup and view all the answers

Which method is NOT used for the purification of water?

Filtration Signup and view all the answers

What type of water is also referred to as deionized water?

Purified water Signup and view all the answers

Which of the following statements about ion exchange is correct?

Ion exchange eliminates the need for heat in water purification. Signup and view all the answers

What is a primary function of cationic exchangers in ion exchange?

To exchange cations with hydrogen ions Signup and view all the answers

Why might ion exchange be preferred over distillation for water purification?

It requires less operational maintenance. Signup and view all the answers

Which type of ion exchange resin is used for removing cations?

Cationic resin Signup and view all the answers

What is the primary purpose of using purified water in pharmaceutical preparations?

To ensure a low level of impurities Signup and view all the answers

What is the primary purpose of water purification using ion exchange resins?

To exchange calcium and magnesium cations for sodium or hydrogen cations Signup and view all the answers

In reverse osmosis, the flow of water through the membrane is driven by which of the following?

Chemical potential Signup and view all the answers

What is a key characteristic of the semipermeable membrane used in reverse osmosis?

It blocks the passage of large molecules while allowing solvents to pass Signup and view all the answers

Which filtration process can remove particles defined in the range of less than 0.001 µm?

Reverse osmosis Signup and view all the answers

What percentage of ions can reverse osmosis effectively remove from water?

90% to 99% Signup and view all the answers

What type of water is characterized as pyrogen-free and must be used within 24 hours after collection?

Purified water Signup and view all the answers

What is the primary component of most commercial resins used in water softening?

Polystyrene sulfonate Signup and view all the answers

Which of the following processes is not part of the filtration presented?

Vacuum filtration Signup and view all the answers

What is the primary use of water for injection?

As a solvent or diluent for injectable medications Signup and view all the answers

Which method is used to achieve sterilization of water for injection?

Autoclaving Signup and view all the answers

What is a key feature of bacteriostatic sodium chloride injection?

It contains a bacteriostatic agent Signup and view all the answers

What is the maximum size for a single dose container of sterile water for injection?

1000ml Signup and view all the answers

Why are oral rehydration solutions (ORS) used?

To replenish electrolytes due to diarrhea Signup and view all the answers

Which of the following is not a component of the typical formulation used in ORS?

Insulin Signup and view all the answers

What is an important consideration when using sterile water for injection?

It is intended for injectable medications only Signup and view all the answers

What is the recommended composition of electrolytes in ORS?

45 mEq sodium, 35 mEq chlorine, 20 mEq potassium, 30 mEq citrate, 25g dextrose Signup and view all the answers

What is the primary purpose of laxatives such as lactulose?

To treat constipation by softening stool Signup and view all the answers

Which component is generally used in mouthwashes to enhance the solubility of the active agent?

Alcohol Signup and view all the answers

What is the main function of viscosity-enhancing agents in retention enemas?

To aid retention and reduce seepage Signup and view all the answers

What is a key property of vaginal preparations?

Maintain optimal pH Signup and view all the answers

What are evacuation enemas primarily used for?

To cleanse the bowel Signup and view all the answers

Which of the following is NOT typically found in formulations designed for mouthwashes?

Electrolytes Signup and view all the answers

What is the role of co-solvents like alcohol in oral cavity treatments?

To enhance the antimicrobial properties Signup and view all the answers

Which statement is true regarding the use of enemas for systemic absorption?

Hydrocortisone can be absorbed locally Signup and view all the answers

Study Notes

Solvents for Pharmaceutical Use

Water: Purified water, widely used, dissolves polar and semi-polar substances, miscible with water, used internally, and has antimicrobial activity.
Ethanol (C₂H₅OH): Dissolves polar and semi-polar substances, miscible with water, used internally, has antimicrobial activity.
Isopropyl alcohol (70%): External use, vehicle for topical preparations.
Glycerin (CH₂OHCHOHCH₂OH): Clear, viscous liquid with sweet taste, miscible with water and alcohol, viscous liquid, miscible, substitute glycerin in pharmaceutical preparations.
Propylene Glycol (CH₃CH(OH)CH₂OH): Viscous liquid, miscible, substitute glycerin in pharmaceutical preparations.
Corn oil, Cottonseed oil, Peanut oil, Sesame oil: Organic solvents for oleaginous injection.

Additives: Buffers

pH required: 7.4 for injectable solutions, eye, nose; 5.5 for dermal application (vaginal 4-5).
Buffering capacity.
Compatibility with other excipients.
Low toxicity.
Carbonates, citrates, gluconates, lactates, phosphates, and tartrates are widely used.
Borates are used for external application, but not on abraded skin or internally.

Taste Masking

Salty: Apricot, butterscotch, liquorice, peach, vanilla.
Bitter: Anise, chocolate, mint, passion fruit, wild cherry.
Sweet: Vanilla, fruits, berries.
Sour: Citrus fruits, liquorice, raspberry.

Additives: Colors

The color of the product is associated with the flavor.
Mint: Green
Chocolate: Brown
Cherry/Strawberry: Pink/Red
Product identification
Safe and acceptable

Solvents: Water USP

Drinking water must be clear, colorless, odorless, and neutral or only slightly acid or alkaline.
Not accepted for manufacture of aqueous pharmaceutical preparations due to chemical compatibility issues with dissolved solids in the medicinal agents (ppt, discoloration, effervescence).
Used for washing, in extraction of crude vegetable drugs.

Purified Water USP

Prepared from tap water complying with the Environmental Protection Agency for drinking water.
Purified water has fewer solids impurities than ordinary drinking water. When evaporated to dryness, it must not yield more than 1 mg solids per 100 mL water.
Intended for use in preparation of aqueous dosage forms, except those intended for parenteral administration.
Used in preparation of all medications containing water, except injectable preparations and other specialized products.
Purification methods: Distillation, De-ionization (ion exchange), Reverse osmosis.

Distillation Method

Distilled water: Water with impurities removed through distillation.
Distillation process involves boiling water, then condensing the steam into a clean container.

Ion Exchange Method

Ion exchange method eliminates the need for heat and costly maintenance of complex distillation apparatus.
Simpler equipment and method for water purification lead to easier operation, minimal maintenance, and greater mobility.
Purified water in this method is referred to as demineralized or deionized water and is used in pharmaceutical preparations and prescriptions that require distilled water.

Ion Exchange Resin or Polymer Beads

Water-insoluble synthetic polymeric resin with high molecular weights, containing phenolic, carboxylic, amino, or sulfonated groups.
Beads are typically porous, providing high surface area.

Ion Exchange Polymer Types

1-Acid or cationic exchanger: Permits exchange of cations in solution with hydrogen ions from the resin.
2-Base or anionic exchanger: Allows removal of anions.

Water Softener

Ion exchange is a method widely used in water filters to produce soft water.
The process involves trapping calcium (Ca²⁺) and magnesium (Mg²⁺) cations against sodium (Na⁺) or hydrogen (H⁺) cations.
Commercial resins are made of polystyrene sulfonate, having higher affinity for divalent cations than monovalent cations.

Reverse Osmosis

Reverse osmosis is a process for membrane filtration, where the flow is from a more concentrated solution to a less concentrated one.
The flow through the semipermeable membrane is from a less concentrated solution to a more concentrated solution.
Reverse osmosis removes virtually all viruses, bacteria, pyrogens, and organic molecules, and 90-99% of ions.
Depending on pore size:
- Microfiltration (0.1-2 μm): Bacteria
- Ultrafiltration (0.01-0.1 μm): Viruses
- Nanofiltration (0.001-0.01 μm): Organic compounds
- Reverse osmosis (particles <0.001 μm)

Solutions Water for Injection

Pyrogen-free water (polysaccharide byproduct of bacterial origin).
Purified by distillation and used within 24 hours after collection.
Intended to be used as a solvent for parental products to be sterilized after preparation.
Sterilization achieved by autoclave (steam under pressure).

Sterile Solutions- Sterile Water for Injection USP

Sterilized and packed in suitable single-dose containers, preferably Type I glass, not exceeding 1000mL size.
Used as solvent, vehicle, or diluent for already sterilized and packaged injectable medications.
Used to reconstitute antibiotics.

Sterile Solutions- Bacteriostatic Water for Injection USP

Sterile water for injection containing a bacteriostatic agent (benzyl alcohol).
Packed in single-dose containers (not larger than 5 mL) or multiple-dose containers (not larger than 30 mL).
Not used for neonates.

Other Sterile Diluents

Sodium chloride injection USP
Bacteriostatic sodium chloride injection USP
Ringer injection USP
Lactated Ringer injection USP
Dextrose 5% solution

Ophthalmic Solutions

Sterile, by autoclave or filtration
Isotonic
Preserved (e.g., phenyl ethyl alcohol, chlorobutanol, benzalkonium chloride, phenyl mercuric nitrate)
Optimum pH, low buffer capacity

Oral Solutions

Final solution components:
- Sweetening agent
- Flavoring agent
- Preservative
- Colors
- Buffers
- Density modifiers
- Viscosity enhancers
- Reducing agents
Types of oral solutions: Dry for reconstitution (unstable in aqueous media, uniform dose)

Oral Rehydration Solution (ORS)

Used for diarrhea to replenish electrolytes.
Contains: 45 mEq sodium, 35 mEq chlorine, 20 mEq potassium, 30 mEq citrate, and 25 g dextrose per liter of fluid.
Available as liquid or powder/packets for reconstitution.

Oral Colonic Lavage Solution

Used before bowel procedures (colonscopy).
Balanced solutions of electrolytes with PEG-3350,
Lactulose is a colonic acidifier that increases stool water content and softens the stool; a man-made sugar solution laxative to treat constipation.

Mouthwashes and Gargles

Designed for treatment of oral cavity infections and inflammation.
Water is the vehicle, but co-solvents (e.g., alcohol) may be employed to solubilize active ingredients.
Alcohol may enhance antimicrobial properties.
Other components (preservatives, colors, flavoring agents, non-cariogenic sweetening agents) enhance palatability.

Vaginal Solutions (Douches)

Used for irrigation, cleansing, hygienic effect.
Astringents, antimicrobials.
pH adjusting agents.
Powders, liquid solutions, or concentrates.
Used externally or internally.

Rectal Solutions (Enemas)

Retention enemas: Local effect (hydrocortisone), systemic absorption (aminophylline).
Evacuation enemas: Used to cleanse the bowel.
Administered rectally. May include viscosity-enhancing agents (e.g., glycerol) to aid retention and reduce seepage.

Evacuation Enemas

Pharmaceutical solutions administered rectally to clear the bowel.
Oil-based solutions aid bowel evacuation, e.g., arachis oil.
Aqueous formulations (e.g., phosphates) alter osmolality, increase rectal water content.
Increases water in large bowel (osmotic laxatives).

Topical Solutions (Infection)

Concentration and vehicle for various topical solutions used to treat infections.

Topical Solutions

Drug, Concentration, Vehicle, Use
Fluorouracil, 2.5%, PG, antineoplastic
Minoxidil, 2.5%, Alcohol, water, PG, Baldness
Hydroquinone, Water Alcohol,, PG
Podophyllum, Benzoin tincture, Warts
Fluocinolone acetonide, PG, Adrenocortical steroid
Betamethasone,
Mometasone

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Test your knowledge on pharmaceutical preparations with this quiz. It covers essential topics such as solvents, flavoring agents, and the quality of injectable solutions. Perfect for students and professionals in the pharmaceutical field!