Compounding III: Documentation & Preparation

Study Notes

Compounding Definitions and Techniques

Comminution: Reducing particle size through grinding, crushing, or milling.
Trituration: Thorough mixing and grinding, often used for tablets in a mortar and pestle.
Levigation: Similar to trituration but includes a levigating agent to assist grinding; performed in a mortar and pestle.
Spatulation: Mixing powders on an ointment slab with a spatula.
Pulverization by intervention: Dissolves crystalline powders in a solvent, resulting in finer particles upon evaporation.

Solution Preparation

A solution consists of a solute in a solvent, resulting in a homogeneous mixture such as syrups or elixirs.
Solubility depends on temperature; Fick's First Law calculates dissolution rates.
Increasing surface area, stirring, and applying heat can enhance dissolution.
Solutions may require a buffer for pH stability and preservatives to inhibit microbial growth.

Suspension Characteristics

A suspension is a heterogeneous mixture of solid particles in a liquid.
Wetting agents help disperse the solid within the liquid; the mixture should be shaken to re-dispersed easily.
Stability is key; good suspensions do not rapidly precipitate.

Emulsions and their Preparation

Emulsions are formed by dispersing one liquid in another, often requiring an emulsifier to lower surface tension.
The Continental method (dry gum) involves mixing oil, water, and an emulsifier in a specific ratio, trituration until creamy.
The English method (wet gum) begins with emulsifier and water to form a mucilage before oil is added.

Powders and Excipients

Excipients enhance powder flowability; glidants like magnesium stearate are commonly used.
The concept of eutectic mixtures allows components to melt at lower temperatures.
Adsorbents maintain powder dryness and stability.

Capsule Formulation

Capsules can be made from gelatin or hypromellose, filled with active compounds and excipients.
Plasticizers like glycerol ensure capsules are flexible rather than brittle.

Tablets Overview

Compounded tablets are typically molded, while manufactured tablets are generally compressed.
Tablets consist of active drugs and additional excipients for stability and usability.

Lozenges and Usage

Lozenges are designed for local oral medication delivery, featuring various ingredients based on texture.

Ointment Preparation

Ointments require thorough trituration of powders with an appropriate levigating agent.
Ingredients are mixed using geometric dilution and, when necessary, heated via the fusion method.

Gels for Drug Administration

PLO gel incorporates lecithin and poloxamer polymers for transdermal drug delivery, acting as a thermoresponsive gel.

Suppositories Composition and Preparation

Bases for suppositories can be oil-soluble or water-soluble.
Manufacturing techniques include hand molding, fusion molding, and compression molding.

Beyond-Use Dates (BUD) Guidelines

Nonaqueous formulations are to be used before the expiration of the API or 6 months.
Water-containing oral solutions have a BUD of 14 days under refrigeration.
Topical preparations have a BUD of 30 days at room temperature.

Sterile Compounding Risk Levels

Low-risk sterile compounding typically involves 1-3 sterile additives, done in a cleanroom setting.
Medium-risk sterile compounding introduces more than three sterile additives, increasing contamination risk.
High-risk sterile compounding involves non-sterile ingredients, requiring subsequent sterilization before use.

BUD for IV Compounding

Compounded sterile preparations have specific BUDs based on risk; for low-risk products, BUDs at room temperature is 48 hours, while refrigerated conditions allow for 14 days.

Description

Explore key concepts in the documentation and preparation of compounded medications through this set of flashcards. Learn about critical processes such as comminution, trituration, levigation, and spatulation, which are vital in achieving the desired particle size and consistency in pharmaceutical preparations.