Oral Dose Terminology

Oral Dose Terminology

Pill banner

Active Pharmaceutical Ingredient (API)
The API is the biologically active ingredient(s) that produce intended effects on a patient. The physicochemical properties of the API affects the formulation and manufacturing of an oral drug in many ways including handling, storage, stability, and shipping.

Bilayer Tablets
Bilayer tablets are medicines that consist of one or more drugs combined in a single dose for effective treatment of the disease.

Biopharmaceutics Classification System (BCS)
The biopharmaceutics classification system (BCS) is a system classifying a drug substance based on their solubility and permeability.
Class I - high permeability, high solubility
Class II - high permeability, low solubility
Class III - low permeability, high solubility
Class IV - low permeability, low solubility

The proportion of a substance or drug that enters systemic circulation when the substance is introduced to the body and can have an therapeutic effect.

Capsules include medication enclosed in an outer shell. This outer shell is broken down in the digestive tract and the medication is absorbed into the bloodstream and distributed and metabolized in much the same way as medication from a tablet. Capsules may contain medications in solid, liquid, or paste form.

Chewable Tablets
Chewable tablets are an oral dosage form intended to be chewed and then swallowed by the patient rather than swallowed whole. They should be designed to be palatable and easily chewed and swallowed.

Coated Tablets
Coated tablets (sugar or film coated) are designed to control the release profile of the drug, mask odor and taste, ease of swallowing, minimize handling exposure of toxic drug, or simply for aesthetic purposes. The coating layer may also protect the tablet from external elements such as humidity and oxygen.

Current Good Manufacturing Practices (cGMP)
The United States FDA sets the cGMP standards and enforces the regulations. cGMP also provides guidelines for a variety of systems to assure proper design, monitoring, and control of pharmaceutical manufacturing processes and facilities. By following the cGMP regulations, patients can be assured that the identity, strength, quality, and purity of drug products have been properly produced by a CDMO or manufacturer.

DEA-Controlled Substances (Schedule I-V, L1)
The Controlled Substances Act (CSA) places all substances which were in some manner regulated under existing federal law into one of five schedules. This placement is based upon the substance’s medical use, potential for abuse, and safety or dependence liability.

Delayed Release
These medications are designed to release the active ingredient(s) later after dosing to help control where the drug is released in the body (e.g., small intestines). This is usually done to prevent the medication from being broken down too early or lessen potential side effects.

Drug Repurposing
The process of identifying new therapeutic use(s) for old/existing/available drugs. It is an effective strategy in discovering or developing drug molecules with new pharmacological/therapeutic indications.

Liquid disperse systems in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible.

Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration. An excipient is an inactive substance formulated with the active ingredient (API) .

Geriatric and Pediatric Formulations
Pediatrics and geriatrics both represent highly heterogenous populations and require special consideration when developing appropriate dosage forms. Arguably the most significant compliance challenge in older people is polypharmacy, whereas for children the largest barrier is taste.

Hard Gelatin Capsules
Two-piece shells made with gelatin that may encompass one or more drug in one or more physical forms like powder, pellet, tablet, small capsule or a combination. Hard gelatin capsules are manufactured by dipping the pins in gelatin solution. After, the gelatin films on pins are dried, trimmed, and then removed from pins to form the body and cap.

Highly Potent Compounds (HPAPI)
A high-potency active pharmaceutical ingredient (HPAPI) can be a novel compound of unknown potency and toxicity. However HPAPI is generally a pharmacologically-active ingredient or intermediate with biological activity at approximately 150μg/kg of body weight or below in humans (therapeutic daily dose at or below 10mg). An API or intermediate with an occupational exposure limit (OEL) at or below 10μg/m3 of air as an 8-hour, time-weighted average; sex hormones and certain other steroids; or a pharmacologically-active ingredient or intermediate with high selectivity with the potential to cause cancer, mutations, developmental defects or reproductive toxicity at low doses. About 25% of drugs globally are based on highly potent active pharmaceutical ingredients.

Hormones are the body’s chemical messengers that are secreted directly into the blood, which carries them to organs and tissues of the body to exert their functions. Many hormones act on different aspects of bodily functions and processes, such as development and growth, metabolism, sexual function and reproductive growth and health, cognitive function and mood, and maintenance of body temperature and thirst.

Immediate Release
Tablets that are intended to dissolve or disintegrate in the stomach within a short period of time are called immediate-release tablets.

The substance’s ability to be dissolved in fats, oils, and lipids. Typically, higher lipophilicity of a drug means greater distribution and binding to targets. Lipophilicity affects the solubility of a drug.

Liquid Filled Hard Gelatin Capsules
Non-aqueous liquid filled in hard gelatin capsules. Benefits include: Effective distribution of substances that do not dissolve in water; higher concentration of drugs can be incorporated; the ability to avoid co-solvent products (two or more separate substances); improved resistance to drug degradation; easy to swallow for patients; and masking of unpleasant taste.

Modified Release
Formulations in which the rate or site of release of active ingredients is different from that of immediate-release dosage forms administered by the same route of administration are called modified release.

Multiple APIs
A drug product that has multiple Active Pharmaceutical Ingredients (APIs) that all participate in producing the intended effects to a patient.

The process by which the particle size of an API is reduced in a liquid vehicle (typically aqueous) via grinding using polymeric or ceramic media. Nano-milling is a commercially validated process for formulating poorly water-soluble APIs.

Orally Administered Drugs
These are taken by a patient through the mouth. Orally administered drugs form of delivery is the most common, convenient, and, typically, the safest for patients. Some common orally administered drugs include: tablets, hard gelatin capsules, soft gel capsules, coated tablets, and powders.

Orally Disintegrating Tablets
Orally disintegrating tablets (ODTs) provide an alternative to tablets and capsules, particularly for pediatric and geriatric patients. ODTs resemble a traditional tablet, but have one important difference: they disintegrate rapidly in the mouth, and therefore do not need to be swallowed.

Particle Engineering
Particle engineering involves obtaining the optimal particle size and size distribution, as well as other aspects of the particle's morphology and surface characteristics used to improve bioavailability and homogeneity for oral solid dosage drugs and to prepare inhaled therapies.

Pediatric Dosage Forms
It is necessary for pediatrics to have access to dosage forms that are capable of safely delivering the dose to the child in an easy and reliable fashion. Many pediatric-specific drug delivery systems are present and include oral liquids, mini-tablets, chewable tablets, and orodispersible technologies.

Powders and Granules
Powders are mixtures of active drugs and excipients. Powders are the bulk, solid, and dry material in the form of ultrafine particles that freely flow when tilted and shaken. During the granulation process, fine particles are converted to larger agglomerates and are called granules. Granules flow evenly through the hopper of the tablet machine, and hence it enhances the uniformity of APIs in a tablet.

Roller Compaction
Compactors are used to force fine powders between two counter rotating rolls and presses the raw materials into a solid compact. Roll compacters are also called dry granulators.

Soft Gel Capsules
Soft gelatin capsules are made from gelatin and are somewhat thicker than hard gelatin capsules and are plasticized by adding sorbitol or glycerin. Some benefits of soft gel capsules include: effective distribution of substances that do not dissolve in water; a higher concentration of drugs can be incorporated; the ability to avoid co-solvent products (two or more separate substances); improved resistance to drug degradation; easy-to-swallow for patients; and masking of unpleasant taste.

The substance’s ability to be dissolved. This is often looked at in terms of water. Drugs that have poor aqueous solubility tend to require higher dosage amounts. Typically, solubility issues are the most common hurdles in achieving ideal bioavailability. Poor solubility of a drug substance is a major challenge in early oral formulation development. When a drug candidate has poor or low solubility, this can have a major impact on the ability of a drug to be absorbed through a patient’s gastrointestinal tract into systemic circulation.

Solutions are liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents (aqueous or non-aqueous). It may be classified as oral, otic, ophthalmic or topical.

Spray Drying
Spray drying is a method of changing a dry powder from a liquid or slurry by rapidly drying with a hot gas. This is a preferred method of drying of many thermally sensitive materials or materials which may require extremely consistent, fine particle size.

A suspension is a mixture between a liquid and particles of a solid. In this case, the particles do not dissolve. The particles and the liquid are mixed up so that the particles are dispersed throughout the liquid. They are "suspended" in the liquid.

Sustained Release
These medications prolong the medication’s release from a tablet or capsule to get the benefits over a longer period of time. This may mean fewer doses throughout the day.

A nearly saturated sugary viscous aqueous solution in which the medicinal substance or drug is dissolved.

Tablets are defined as solid pharmaceutical dosage forms prepared by compressing drugs, with or without suitable excipients. Tablets come in many shapes and sizes. They include one or more active ingredient combined with excipients (carrier substances that help hold the tablet together) and pressed into tablet form.

Tablet in Tablet
Tablet in Tablet, or compression-coated tablet, consists of two parts; one is an internal drug core, and another is an outside coating shell. The outer layer surrounds the inner core, and it mainly controls the strength of the tablet, the release of the drug, and the stability.

Taste Masking
Taste masking techniques are applied to mask or overcome the bitter or unpleasant taste of active pharmaceutical ingredients/drugs to achieve patient acceptability and compliance. Oral administration of bitter or unpleasant-tasting drugs is often the biggest barrier for patient groups, such as pediatrics and geriatrics.

Tech Transfer
Technology transfer is the transfer of drug product and process knowledge between development and manufacturing, or between two manufacturing sites or organizations.

3D Printing
Also known as additive manufacturing, 3D printing can quickly print customized and individualized oral solid dosage form on demand. By rationally selecting the formulation composition and designing the printing structure, 3D printing can improve the solubility of the drug and achieve precise modification of the drug release.



Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) located in Hunt Valley, Maryland. The experienced scientists, engineers, and staff at Pii pride themselves on adroitly employing a phase appropriate method of drug development for the prudent use of their customer’s resources as they solve challenging problems. In addition to offering end-to-end development services, Pii manufactures a variety of dosage forms to include complex parenteral drugs and has a wealth of analytical testing capabilities. Its Hunt Valley campus has four aseptic suites with lyophilization capabilities. Our talented professionals stand ready to help!