IMC 2: Pharmaceutical Aids

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Questions and Answers

Which type of ointment base is characterized by its hydrophobic nature?

Emulsion type ointment bases

Absorption ointment bases

Water soluble ointment bases

Oleagenous ointment bases (correct)

What is the primary purpose of disintegrating agents in tablet formulation?

To act as diluents and increase bulk

To enhance the flow of granules during manufacturing

To aid in the breakup of a tablet (correct)

To improve the cohesion of powdered materials

Suppositories typically undergo which of the following processes after insertion?

Solidification upon exposure to body temperature

Absorption into the bloodstream without modification

Dissolution in the secretions of the cavity (correct)

Evaporation in the surrounding environment

Which function do binders serve in the formulation of pharmaceutical powders?

They impart cohesive properties to powdered materials Signup and view all the answers

Which group of ointment bases would likely include substances that can mix with water?

Emulsion type ointment bases Signup and view all the answers

What is the primary function of pharmaceutical aids in the manufacturing of dosage forms?

To assist in various processes without therapeutic value. Signup and view all the answers

Which of the following is NOT a category of pharmaceutical aids?

Therapeutic agents Signup and view all the answers

Sodium bisulphite is commonly used as what type of pharmaceutical aid?

Antioxidant and preservative Signup and view all the answers

What are excipients primarily used for in pharmaceutical products?

To serve as inactive substances that aid in drug formulation. Signup and view all the answers

Which of the following is a purpose of buffers in pharmaceutical applications?

Maintain pH stability. Signup and view all the answers

What is the role of filter aids in pharmaceutical manufacturing?

To assist in the filtration process. Signup and view all the answers

Which class of pharmaceutical aids is specifically used to enhance the solubility of active ingredients?

Solvents and vehicles Signup and view all the answers

What defines excipients in the context of pharmaceutical technology?

Inert substances that facilitate dosage form processing. Signup and view all the answers

What is one mechanism by which antioxidants can achieve their action?

Antioxidants can react with active drug constituents. Signup and view all the answers

Which property must an effective antioxidant possess?

Physiological inertness at the concentration being used. Signup and view all the answers

What is the chemical formula for sodium bisulphite?

NaHSO3 Signup and view all the answers

What does sodium bisulphite yield when passing sulfur dioxide into a sodium carbonate solution?

Sodium bisulfite and carbon dioxide. Signup and view all the answers

Which of the following is an important official antioxidant?

Sodium metabisulphite Signup and view all the answers

What is a necessary characteristic of preservatives mentioned in relation to antioxidants?

They can also have bacteriostatic activities. Signup and view all the answers

What happens when bisulphite is neutralized by adding acids?

It yields sulfurous acid. Signup and view all the answers

Which of the following describes the physical appearance of sodium bisulphite?

It occurs as a white granular powder or white crystals. Signup and view all the answers

What is the primary function of NaHSO3 in pharmaceutical uses?

It functions as an antioxidant and stabilizing agent. Signup and view all the answers

Which of the following statements about desiccants is correct?

Some desiccants can retain a rigid crystalline form after moisture absorption. Signup and view all the answers

What role do excipients play in pharmaceutical formulations?

They increase the bulk of the solid mass carrying the drug. Signup and view all the answers

Which of the following compounds is transformed by NaHSO3 to increase its solubility?

Menadione Signup and view all the answers

What type of substance is calcium chloride classified as?

A desiccant Signup and view all the answers

What is a common use of NaHSO3 in medical treatments?

As an antiseptic in gastric fermentation Signup and view all the answers

Which of the following is NOT a function of excipients in pharmaceutical formulations?

Enhancing active ingredient absorption Signup and view all the answers

Which of the following is true regarding the dosage of NaHSO3?

A dose of 0.3 to 0.6 g is used for antiseptic effects. Signup and view all the answers

Which of the following is an example of an excipient?

Magnesium stearate Signup and view all the answers

What is the primary characteristic of magnesium stearate?

It has a greasy texture and is very smooth. Signup and view all the answers

What role does an emulsifying agent play in an emulsion?

It lowers the surface tension between immiscible phases. Signup and view all the answers

Which of the following describes a suspension?

A dispersion of a solid in a liquid that is not completely dissolved. Signup and view all the answers

What is the approximate percentage of magnesium oxide in magnesium stearate?

7.5% Signup and view all the answers

How is magnesium stearate obtained?

By heating stearic acid and magnesium oxide. Signup and view all the answers

In which application is magnesium stearate MOST commonly used?

As a lubricant in tableting. Signup and view all the answers

Which of the following substances is NOT classified as an excipient according to common definitions?

Caffeine Signup and view all the answers

Study Notes

Pharmaceutical Aids

Pharmaceutical aids are chemicals that are used in the manufacture of dosage forms (e.g., ointments, liquids, tablets) but have little or no therapeutic value.
These aids are often referred to as pharmaceutical necessities, and they are essential for various purposes, including preservation, stabilization, acidification or alkalisation, suspending, excipient, adsorption, absorption, filtration, prevention of oxidation, complexation, etc.
Pharmaceutical aids may remain in the final product or be removed during processing.
Quality Control: Pharmaceutical aids are subject to stringent quality control measures because they come into contact with drugs.

Classification of Pharmaceutical Aids

Acidifiers and Alkalisers: These are used to adjust pH of solutions.
Buffers: Used to maintain a specific pH level.
Absorbents and Adsorbents: Absorbents absorb moisture, while adsorbents adsorb molecules onto their surface.
Antioxidants and Preservatives: Protect pharmaceutical products from oxidation, degradation, and microbial growth.
Desiccants: Substances that absorb moisture and provide a dry atmosphere in containers.
Excipients: Increase the bulk of solid masses, carrying a drug. Used in tablets, capsules, powders, granules, and pills. They can act as diluents, binders, disintegrants, coating agents, lubricants, and more.
Suspending Agents: Maintain the uniform distribution of insoluble particles in a liquid.
Filter Aids: Assist in clarifying liquids and removing unwanted particles.
Colorants: Add color to pharmaceutical products.
Tonicity Adjusting Agents: Used to adjust the tonicity of solutions (e.g., for injections).
Solvents and Vehicles: Dissolve or suspend the active ingredient(s).
Coloring, Flavoring, and Sweetening Agents: Improve taste and palatability.
Ointment and Suppository Bases: Form the base of ointments and suppositories, respectively.
Diluents, Binders, Disintegrating Agents, and Lubricants: Used in tablet manufacturing to increase bulk, provide cohesion, facilitate disintegration, and improve flowability.

Sodium Bisulphite (NaHSO3)

Synonym: Sodium hydrogensulphite, sodium acid sulphite, sodium pyrosulphate
Chemical Formula: NaHSO3, molecular weight: 104.06
Preparation: Prepared by passing sulfur dioxide gas into a solution of sodium carbonate.
Physical Properties: A white, granular powder or crystals with a sulfur dioxide odor. Freely soluble in water, slightly soluble in alcohol.
Chemical Properties: Reacts with acids to form sulphurous acid (H2SO3), which decomposes into water (H2O) and sulfur dioxide (SO2).
Pharmaceutical Uses: An antioxidant and stabilizing agent used in injectable solutions, such as epinephrine hydrochloride, phenylephrine hydrochloride, and ascorbic acid. Also used to solubilize menadione (vitamin K) and kidney stones.

Antioxidants and Preservatives

Mechanism of Action (Antioxidants):
- Direct Oxidation: Antioxidant gets oxidized itself, preventing the oxidation of the active pharmaceutical ingredient.
- Reduction: If the active ingredient is oxidized, the antioxidant reduces it back to its original state.
Selection Criteria of Antioxidants:
- Effective at low concentrations.
- Physiologically inert.
- Compatible with the drug (chemically and physiologically).
- Low toxicity of the reducing agent and its oxidized product.
- Soluble in the drug vehicle.
Examples: Sodium sulphite, sodium bisulphite, sodium metabisulphite, sodium thiosulphate, hypophosphorous acid, sodium nitrite, nitrogen, carbon dioxide.

Desiccants

What they are: Substances that absorb moisture.
Purpose: Maintain a dry atmosphere in containers to protect moisture-sensitive pharmaceutical preparations.
Types:
- Liquefying: Absorb moisture and become liquid or form solutions (e.g., calcium chloride).
- Solid: Maintain a crystalline form after absorbing moisture (e.g., silica gel).

Excipients

Function: Increase the bulk of a solid mass carrying a drug.
Uses: Tableting, capsules, powders, granules, and pills. May also act as diluents.
Inert: Do not exert therapeutic actions, but some are active (e.g., antioxidants, preservatives, buffers).
Quality: Subject to the same stringent quality control measures as therapeutic agents because they enter the body.
Examples: Tricalcium phosphate, dibasic calcium phosphate, magnesium stearate, purified talc, calcium carbonate, calcium sulphate.

Magnesium Stearate

Preparation: Neutralization of stearic acid (containing some palmitic acid) with magnesium oxide.
Composition: A mixture of magnesium stearate and magnesium palmitate.
Physical Properties: Very fine, white fluffy powder with a greasy feel and faint odor.
Uses: Dusting powder for cosmetics, skin preparations, barrier creams, and lubricant in tablet manufacturing.

Suspending Agents and Emulsifying Agents

Purpose: Stabilize suspensions and emulsions.
Suspensions: Dispersion of finely divided insoluble material in a liquid medium.
Emulsions: Intimate mixtures of two immiscible phases stabilized by an emulsifying agent.
Emulsifying Agent: An inert substance that homogenizes phases by lowering surface tension.

Ointment and Suppository Bases

Ointment Bases (Classification):
- Oleagenous: Oil-based.
- Absorption: Allow incorporation of aqueous solutions.
- Emulsion: Water-in-oil or oil-in-water emulsions.
- Water-soluble: Water-miscible bases.
Suppositories: Solid dosage forms, generally medicated, to be inserted into body cavities (rectum, vagina, urethra). They melt or dissolve upon insertion.
Suppository Bases: Materials used to formulate suppositories.

Diluents, Binders, Disintegrating Agents, and Lubricants

Diluents: Increase bulk of solid masses.
Binders: Provide cohesion to powdered materials for granulation.
Disintegrating Agents: Facilitate the breakup of tablets.
Lubricants: Improve the rate of flow of granules and prevent adhesion or cohesion during tablet manufacturing.

Solvents or Vehicles

Purpose: Used in pharmaceutical formulations to dissolve or suspend active ingredients.

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Description

This quiz explores the essential role of pharmaceutical aids in the manufacturing of dosage forms. It covers their classification, functions, and the importance of quality control in their use. Test your knowledge on these critical components in pharmaceuticals.