MANUF LAS 10

Pharmaceutical Analysis

The process of evaluating the quality, purity, and effectiveness of pharmaceutical products through various tests and measurements.

Quality Control

The measures and procedures taken to ensure that pharmaceutical products meet the required standards of quality, purity, and effectiveness.

Stability of Pharmaceutical Products

The ability of a pharmaceutical product to maintain its physical, chemical, microbiological, therapeutic, and toxicological specifications over a defined storage period.

cGMPs

Current Good Manufacturing Practice for Finished Pharmaceuticals, a primary regulation issued by the FDA that outlines the requirements for manufacturing pharmaceutical products to ensure their quality and safety.

Formulation Development

The process of creating a stable and effective formulation of a pharmaceutical product, taking into account factors such as stability, compatibility, and clinical requirements.

Expiration Date

The date assigned to a pharmaceutical product based on its stability data, indicating the period during which the product is expected to remain within its specifications.

Distribution Center

A facility where pharmaceutical products are stored and distributed to wholesalers or directly to pharmacies.

Inventory Control

The management and monitoring of pharmaceutical product stock to ensure that products are within their expiration date and remain useful for customers.

Stability Study

A scientifically designed study that uses stability-indicating assays, statistical concepts, and data analysis to determine the accurate shelf life and expiration date of a pharmaceutical product.

Types of Stability

The different aspects of stability that need to be maintained in a pharmaceutical product, including chemical, physical, microbiological, therapeutic, and toxicological stability.

Stability studies

Studies conducted to determine the shelf life and expiration date of pharmaceuticals by predicting the approximate time at which the probability of stability failure may reach an intolerable level.

Expiration dating

The date assigned to a pharmaceutical product indicating the time after which it is no longer expected to be effective or safe for use.

Type 2 error

Also known as a beta error, it refers to setting the expiration date too late, resulting in a higher proportion of stability failures occurring.

Shelf life prediction

The process of determining the expected duration for which a pharmaceutical product will remain stable and maintain its quality.

Physical stability failures

Failures related to changes in the physical properties of a pharmaceutical product, such as drug release rate, appearance, or dosage form properties.

Chemical stability failures

Failures related to chemical changes in a pharmaceutical product, such as incompatibility, oxidation, reduction, hydrolysis, racemization, and other mechanisms.

Pharmaceutical dosage forms

Different forms in which pharmaceutical products are available, each presenting unique stability problems.

Tablets

Solid dosage form that should retain its size, shape, weight, and color throughout its shelf life.

Tablet friability

The tendency of tablets to crumble or break when subjected to mechanical stress, measured by determining the amount of material worn away by abrasion.

Tablet hardness

The resistance of tablets to crushing or fracturing, assessed using hardness testers.

Color stability

The ability of tablets to maintain their original color throughout their shelf life.

Dissolution

The process by which a solid dosage form dissolves in a liquid medium, often used as an in vitro test to estimate bioavailability.

Dissolution method

A method used to determine the correlation between the bioavailability of a dosage form and its dissolution profile.

Dissolution profiles

The examination of the concentration ranges at set sampling points during the development of controlled release drug products for product assessment.

Immediate release product

A dosage form that releases the drug immediately upon administration.

In vivo bioavailability

The rate and extent to which a drug is absorbed and becomes available at the site of action in the body.

Uniformity of weight

Ensuring that each tablet or capsule in a batch has the same weight.

Gelatin Capsules

Capsules made from gelatin that are used in the production of pharmaceutical products.

Hard gelatin capsules

The type of gelatin capsules used by pharmaceutical manufacturers and pharmacists in compounding prescriptions.

Soft gelatin capsules

Gelatin capsules prepared with the addition of glycerin or a polyhydric alcohol to make the gelatin elastic or plastic-like.

Hygroscopic

Materials that have a tendency to absorb moisture from the environment.

Deliquescent

Materials that have a tendency to absorb moisture from the environment and dissolve in the absorbed water.

Cross-linking

An irreversible chemical reaction that occurs in gelatin capsules exposed to excessive heat, moisture, aldehydes, or peroxides, leading to delayed or incomplete dissolution.

Pellicle formation

The formation of a thin film or layer on the surface of a substance.

Digestive enzymes

Enzymes in the body that break down food and other substances.

Suspensions

Pharmaceutical formulations in which solid particles are dispersed in a liquid medium.

Flocculated suspension

A stable suspension in which the suspended particles are bonded together physically to form a loose, semi-rigid structure.

Non-flocculated suspension

A suspension in which the particles remain as individuals and settle slowly, forming a hard sediment.

Differential manometer

A device used to determine if a suspension is flocculated by measuring the hydrostatic pressures in two arms of liquid.

Brookfield viscometer

An instrument used to measure the resistance encountered by a rotating T-bar spindle in a sedimented suspension.

Particle size distribution

The range of particle sizes present in a suspension.

Crystal form alterations

Changes in the crystal structure of a substance.

Suspension

A mixture in which solid particles are dispersed in a liquid medium.

Shipping tests

Tests conducted to study the stability of suspensions by transporting bottles across the country by rail or truck.

Stable solution

A solution that retains its original clarity, color, and odor throughout its shelf life.

Physical stability program

A program focused on maintaining the clarity of a solution, often using a microscope light to detect undissolved particles.

Light-scattering instruments

Instruments used to measure solution clarity by detecting scattered light caused by undissolved particles.

Cycling temperature conditions

Subjecting solutions to varying temperature ranges to test their stability.

pH changes

Changes in the acidity or alkalinity of a solution, especially relevant for solutions containing soluble salts of insoluble acids or bases.

Emulsion

A mixture of two immiscible liquids, typically oil and water, stabilized by an emulsifier.

Oil in water (O/W) emulsion

An emulsion where oil is dispersed as small droplets in water.

Water in oil (W/O) emulsion

An emulsion where water is dispersed as small droplets in oil.

Gross physical stability

The overall stability of an emulsion, often determined by observing changes in appearance or turbidity when heated.

Coalescence time test

A test used to estimate emulsion stability by measuring the time it takes for droplets to coalesce or merge.

Ultracentrifuge

A device used to determine emulsion stability by measuring the separation of oil from the emulsion under centrifugal force.

Ointment

A high-viscosity suspension of active ingredients in a non-reacting vehicle.

Bleeding

The separation of fluid components, such as mineral oil, from an ointment, resulting in visible layers.

Consistency

The physical property of an ointment that determines its texture and ease of use.

Penetrometer

An apparatus used to measure the consistency of an ointment by measuring the depth of penetration of a pointed weight.

Helipath

A method or apparatus used to measure the consistency of an ointment.

Ointment

A semi-solid preparation that is applied to the skin for medicinal or cosmetic purposes.

Rheometer

An instrument used to measure the flow and deformation of materials, such as ointments, under applied forces.

Equilibrium

A state of balance or stability that a substance or system reaches after a certain period of time.

Stability study

A series of tests and evaluations performed to determine the physical and chemical stability of a product over time.

Transdermal patch

A patch that delivers medication through the skin and into the bloodstream.

Pharmaceutically elegant

Refers to the appearance and quality of a pharmaceutical product, ensuring it remains visually appealing and effective throughout its shelf life.

Metered-dose aerosols

Inhalation products that deliver a specific dose of medication in aerosol form.

Dry-powdered inhalation products

Inhalation products that deliver medication in a dry powdered form.

Nasal inhalation products

Inhalation products that deliver medication through the nasal cavity.

Incompatibility

The inability of two or more substances to coexist without undergoing chemical reactions or physical changes.

Hydrolysis

A chemical reaction in which a compound reacts with water, resulting in the breaking of chemical bonds.

Epimerization (racemization)

The process in which a stereoisomer converts into its mirror image stereoisomer.

Decarboxylation

The removal of a carboxyl group from a molecule, often resulting in the release of carbon dioxide.

Dehydration

The removal of water molecules from a compound or substance.

Oxidation

A chemical reaction in which a substance loses electrons, resulting in an increase in its oxidation state.

Polymerization

The process of combining monomers to form a polymer.

Photochemical decomposition

The breakdown of a compound or substance due to exposure to light.

Addition

A chemical reaction in which two or more substances combine to form a single product.

Preferential degradation

The process in which certain substances are broken down or degraded more readily than others.

Chain inhibitors

Substances that prevent the propagation of free radicals by providing an electron and absorbing excess energy.

Antioxidant

A compound that helps prevent or inhibit the oxidation of other molecules, thereby reducing damage caused by free radicals.

pH range

The range of acidity or alkalinity in which a substance remains stable and effective.

Soluble

Capable of being dissolved in a liquid.

Colorless

Having no color.

Nontoxic

Not harmful or poisonous.

Nonvolatile

Not easily evaporating or turning into a gas.

Nonirritating

Not causing irritation or inflammation.

Low concentrations

Small amounts or levels.

Thermostable

Able to withstand high temperatures without degradation.

Container-closure system

The combination of a container (e.g., bottle, vial) and closure (e.g., cap, stopper) used to store a pharmaceutical product.

Formulation ingredients

The components used to create a pharmaceutical formulation, such as excipients and active ingredients.

Synergists

Compounds that enhance the activity of antioxidants.

Organic compounds

Compounds containing carbon atoms.

Heavy metal ions

Positively charged metal atoms that have a high atomic weight.

Ethylenediamine tetraacetic acid (EDTA) derivatives

Organic compounds derived from EDTA that can complex heavy metal ions.

Hydrolysis

The chemical reaction in which a compound reacts with water, resulting in the breakdown of bonds and the formation of new compounds.

Ester

A compound formed by the reaction between an acid and an alcohol, with the elimination of water.

Amide

A compound formed by the reaction between an acid and an amine, with the elimination of water.

Imide

A compound containing the functional group -C(O)NH-.

Imines

Compounds containing the functional group -C=N-.