PHAR101B Terms and Dosage Forms

Chemical

the name that describes the molecular structure of a drug

Code or laboratory

the name given to a drug by the research and development investigators

Compendial

the name listed in the United States Pharmacopeia

Official

usually the same as the compedial or generic name

Generic

common name chosen by the company

Proprietary or trade

the name chose by the manufacturing company

Factors that influence the development of a drug and things to consider

1. The physical and chemical characteristics of the active pharmaceutical ingredient (API)

2. The intended use of the dosage form

3. Formulation that includes excipients to insure that the product delivers the drug in a manner defined by the pharmacologist/clinical expert

4. Method of manufacturing

Injectable formulations

Solutions, suspensions, and a range of sustained release formulations

Drenches

a large volume of aqueous suspension or solution containing the API that is pumped into the animal’s rumen

Medicated articles

a formulation intended for administration in feed

Topical products

Skin, ophthalmics, otics, and anti-inflammatory formulations

Transdermal products

skin but systemically absorbed

Transvaginal products

drug release in the urogenital tract and subsequent absorption across the vaginal epithelium

CRYSTALLINE FORM

Condition variables of importance include temperature, pressure, rate of cooling, and time.

PARTICLE GEOMETRY

Plays are role on how the medicine is delivered and how it interacts with the body – cellular uptake, tissue penetration, and biodistribution.

DISSOCIATION CONSTANTS / pKa

The pKa of a drug influences lipophilicity, solubility, protein binding, and membrane permeability.

PARTITION COEFFICIENTS

Ability of drug to cross the biological membranes before entering the bloodstream.

SOLUTIONS

clear, homogeneous liquid dosage form that contains one or more APIs dissolved within a vehicle

SUSPENSIONS

A liquid suspension is a dosage form containing solid particles dispersed in a liquid vehicle.

EMULSIONS

Emulsions are a fluid system consisting of two immiscible phases, leading to liquid droplets (containing the API) which are dispersed in the solvent.

SUSPOEMULSION

a combination of a suspension and emulsion.

PASTES

a semisolid dosage form containing a large proportion of solids finely dispersed in a fatty vehicle

GELS

a semisolid dosage form in which a liquid phase is constrained within a three-dimensional cross-linked matrix

LOTIONS

suspensions intended for external applications

CREAM

a semisolid emulsion system (o/w, w/o) containing more than 10% of water

OINTMENT

a highly viscous or semisolid preparation intended for external application

TABLETS

compressed powders prepared by one of three general methods: wet granulation, dry granulation, and direct compression

BOLUS

is a very large tablet that is intended to be retained in the rumen

IMPLANTS

is a very small tablet that is manufactured in the same way as a tablet. It is a nonoral dosage form that can remain in the body of the animal for many months

CAPSULES

solid dosage forms in which the drug is enclosed in a hard or soft soluble shell. The shells are usually made from a gelatin, cellulose, or polymeric material.

Compounding (RA 10918 Pharmacy Law)

refers to the sum of processes performed by a pharmacist in drug preparation including the calculations, mixing, assembling, packaging, or labeling of a drug: (1) as the result of a prescription or drug order by a physician, dentist, or veterinarian; or (2) for the purpose of, or in relation to, research, teaching, or chemical analysis

Compounding (FDA)

The process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA approved.

Componding (USP old)

The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice

Componding (USP 2022 revision)

combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or other altering a drug product or bulk drug substance to create a nonsterile preparation

Animal Medicinal Drug Use Clarification Act of 1994

AMDUCA stands for

AMDUCA

permits veterinarians to prescribe extra-label use of certain approved new animal drugs and approved human drugs for animals under certain conditions.

food animals and nonfood animals

AMDUCA divided patients into ___ based on intended use and described when off-label use would be appropriate for each group

Dosage Form, Dosage Strength, Flavoring, Eliminating Ingredients, Availability

Benefits of Compounded Products

Binder, Coating, Coloring Agent, Disintegrants, Emulsifiers, Fillers/Diluents, Flavor Agents, Flow Agents, Humectants, Preservatives, Sweetening agents, Thickening agents

Inactive ingredients

Oral, Transdermal, Topical, Subcutaneous, Intravenous, Intramuscular

ROUTES OF ADMINISTRATION

DOSAGE FORM

Wide variety of species and size variation within many animal species it is not practical to have products readily available in the appropriate dosage forms for every patient.

DOSAGE FORM

There may also be specific patient and caregiver preferences regarding which dosage forms is easiest to administer.

DOSAGE STRENGTH

The same species and size variety also creates a need for dosage strengths that are not commercially available.

DOSAGE STRENGTH

When compounding for the purpose of creating a new dosage strength, it is important to ensure that there is a clinical difference between the compound and the commercially available option

FLAVORING

Addition of flavoring can be helpful to facilitate compliance.

FLAVORING

A wide variety of flavor can be added to oral medications to create an enticing smell and/or an acceptable taste for a patient.

ELIMINATING INGREDIENTS

Sometimes there is an FDA approved product available in the desired strength and dosage form, but it contains an inactive ingredient that is toxic to the species, or a particular patient is not able to tolerate

ELIMINATING INGREDIENTS

Presence of XYLITOL is avoided in making drugs for small animals

Birch sugar, Wood sugar, Birch bark extract, “XYL”, “Other sugar alcohol”

OTHER NAMES OF XYLITOL

AVAILABILITY ISSUES

It is important to note that when the approved product becomes available again, the compounding of the duplicate must cease.

INCORRECT POTENCY, INCORRECT INGREDIENT, LACK OF STABILITY, LACK OF EFFICACY, LACK OF SAFETY, EXCESSIVE MICROBIAL GROWTH OR LACK OF STERILITY

Risk of Compounded Products