Technical data

160
Dissolution Testing – General Information
Major organizations and groups that influence disso-
lution testing standards in the US:
In the United States, Dissolution testing for pharmaceuti-
cal products in tablet and capsule form is required by the
US Food and Drug Administration (FDA). The standards
for testing are put by the US Pharmacopoeia (USP).
Testing procedures are described in USP general chap-
ters under Dissolution <711> and Drug Release <724>.
These standards offer different test apparatuses to use
according to the nature of the dosage form.
U.S. Pharmacopeia (USP)
The United States Pharmacopeia (USP) is a nongovern-
mental, standards-setting organization that advances
public health by ensuring the quality and consistency of
medicines, promoting the safe and proper use of medica-
tions, and verifying ingredients in dietary supplements.
USP provides standards for more than 4,000 prescription
and non-prescription drugs, dietary supplements, veteri-
nary drugs and health care products. These standards
are published in the United States Pharmacopeia and
National Formulary (USP–NF). www.usp.org.
US Food and Drug Administration (FDA)
The FDA’s major contribution to dissolution testing is its
issuance of numerous documents titled “Guidance for
Industry” that describe how to apply the similarity factor.
The similarity factor is used to compare the dissolution
profiles of different batches to assess or establish bio-
equivalence.
The FDA co-sponsors many workshops (e.g. from AAPS)
and conferences on current regulatory issues.
www.fda.gov.
Fédération Internationale Pharmaceutique (FIP)
FIP is a world-wide federation of national pharmaceutical
(professional and scientific) associations, which has a
mission to represent and serve pharmacy and pharma-
ceutical sciences around the globe. FIP spearheaded the
writing of the Guidelines for Dissolution Testing of Solid
Oral Products. The guidelines were published as a joint
report with Canada’s Official Laboratories and Medicines
Control Services and FIP’s Section of Industrial Pharma-
cist. The main focus of the FIP Dissolution Working Group
is to provide a forum for discussion of dissolution issues
and to train dissolution analysts. The working group has
sponsored and held many training workshops on dissolu-
tion testing. Workshops were held in Vietnam and in
Thailand.The equipment was made available by
ERWEKA on both workshops.
Homepage: www.fip.org.
American Association of Pharmaceutical Scientists
(AAPS)
AAPS is a professional, scientific society of more than
10,000 members employed in academia, industry, gov-
ernment and other research institutes worldwide. The
AAPS sponsors many short courses, workshops, and
conferences dedicated fully or in part to dissolution test-
ing.
Official Methods of Dissolution Testing and the cor-
responding ERWEKA equipment:
United States Pharmacopoeia: USP XXVI (26)
European Pharmacopoeia: Ph.Eur 7 th Edition
British Pharmacopoeia: BP
Japanese Pharmacopoeia
USP Apparatuses:
USP Apparatus 1: Rotating Basket
USP Apparatus 2: Paddle
USP Apparatus 3: Reciprocating Cylinder
USP Apparatus 4: Flow-Through Cell
USP Apparatus 5: Paddle over Disc
USP Apparatus 6: Rotating Cylinder
USP Apparatus 7: Reciprocating Holder
ERWEKA Dissolution Testers for USP apparatus 1
(Basket), 2 (Paddle), 5 (Paddle over Disc) and 6 (Ro-
tating Cylinder) are available in 2 standard versions,
namely DT DT 720 and DT 820 series with 8
USP/Pharm.Eur. vessels (1.000 ml or 2.000 ml volume)
and 6, 7 or 8 test stations (stirrers).
Most ERWEKA Dissolution Testers are available in 2
versions, "Low-Head" for easy manual sampling as well
as automated sampling and low evaporation (max. 0.3%
within 24 h at 37.0°C) and "High-Head" for maximum
access to the vessels during the complete test run.
Special versions with 3 test stations of 4.000 ml and 1 test
station of 1.000 ml (reference) as well as Dual Dissolution
Testers with 16 USP/Pharm.Eur. vessels and 12 or 14
test stations (stirrers) can be supplied.
ERWEKA Flow-Through-Cell Dissolution Testers for
USP apparatus 4 are specifically made for those prod-
ucts which require long term tests (i.e implants) and
products which need a high amount of media volume to
dissolve (see page 72).
The perfect unit for multiple media change is the
CALEVA BIO-DIS which complies with USP apparatus
3 and optional apparatus 7.
It is the perfect equipment for multiple pH change due to
the 6 rows of vessels, 6 test stations and 2 Reference
Positions each, located in a thermostatically heated water
bath.