Excipient World Conference & Expo

Attendees, exhibitors & solutions

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Industry trends

Key trends shaping this market and its wider industry.

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Frequently asked

Glossary

1

Excipient

Any substance in a medicine other than the active pharmaceutical ingredient, included to aid manufacture, stability, delivery or patient acceptability. In a tablet this might be a filler, binder, disintegrant, lubricant or coating polymer.

2

API (active pharmaceutical ingredient)

The pharmacologically active component of a drug product. At Excipient World the API sits on the other side of the formulation: the focus is what is added around it and how that choice changes processing, stability and performance.

3

Functional excipient

An excipient chosen for a specific performance job rather than as inert bulk, for example a release-controlling polymer or a solubiliser that lifts bioavailability.

4

Co-processed excipient

A particle engineered from two or more excipients to combine functions, such as a filler and binder that together deliver good flow and compactability in direct compression.

5

Direct compression

Tabletting route where blend components are compressed without wet or dry granulation. It puts the emphasis on excipient flow, particle size distribution and compactability.

6

Binder

Excipient that holds powder particles together in granules or tablets, for example PVP, HPMC or pregelatinised starch.

7

Disintegrant

Excipient that breaks a tablet apart on contact with fluid. Superdisintegrants such as croscarmellose sodium and sodium starch glycolate work at low loadings.

8

Lubricant

Excipient, typically magnesium stearate or sodium stearyl fumarate, that reduces friction between the tablet and die wall during compression.

9

Glidant

Excipient such as colloidal silicon dioxide that improves powder flow by reducing inter-particle friction.

10

Film coating system

A formulated polymer blend (for example HPMC with plasticiser and pigment) applied to tablets for taste masking, moisture protection, colour or modified release.

11

HPMC (hypromellose)

Cellulose ether used both as a binder and as a matrix-forming controlled-release polymer. Its viscosity grade and substitution type drive release rate.

12

Microcrystalline cellulose (MCC)

Purified cellulose widely used as a dry binder and filler, valued for compactability and its role in direct compression formulations.

13

Lipid excipient

Oils, fats, phospholipids and PEG-lipids used in lipid-based formulations and lipid nanoparticles; quality attributes include fatty acid profile, peroxide value and purity grade.

14

Bioavailability enhancement

Formulation strategy for poorly soluble drugs, using solubilisers, surfactants, lipids or amorphous solid dispersion carriers to raise exposure.

15

Pharmacopoeial monograph

Published quality standard for an excipient, such as a USP-NF or Ph. Eur. monograph, that sets identity, assay, impurity limits and tests.

16

ICH Q3D elemental impurities

Guideline that sets permitted daily exposure limits for elemental impurities in drug products, driving excipient risk assessment and supplier data requests.

17

Nitrosamine risk assessment

Structured review of whether excipients, solvents or process conditions could form nitrosamines, now a routine supplier questionnaire topic for formulation and quality teams.

18

TSE/BSE statement

Supplier declaration that a material of animal origin carries no risk of transmissible spongiform encephalopathy, required for many excipient qualification files.

19

EXCiPACT certification

Third-party GMP/GDP certification scheme for pharmaceutical excipient manufacturers and distributors, recognised in supplier qualification and audit planning.

20

IPEC

International Pharmaceutical Excipients Council, the industry body whose regional associations set excipient quality, regulatory and safety positions and run the Excipient World programme.

21

Drug Master File (DMF)

Confidential filing, for example a Type IV excipient DMF in the United States, used to support excipient review without disclosing full manufacturing detail to the customer.

22

Supplier qualification audit

On-site or remote assessment of an excipient supplier's quality system, production controls and change-notification practices before approval.

23

Quality by Design (QbD)

Development approach that links excipient material attributes to product critical quality attributes, often via design of experiments and a control strategy.

24

Particle size distribution (PSD)

Distribution of particle diameters in a powder, measured by laser diffraction or sieving and closely tied to blend uniformity, flow and content uniformity.

25

Compactability

A powder's ability to form a tablet of adequate strength under compression; a core selection criterion for fillers and dry binders.

26

Compatibility study

Bench study that tests API and excipient combinations for degradation or interaction before a formulation is locked.

27

Novel excipient

An excipient with no established pharmacopoeial monograph or prior use in the target market, requiring a fuller safety and regulatory package before commercial adoption.