DR Capsules
DRcaps™ capsules, made from a novel
hypromellose formulation, are uniquely
resistant to a low pH environment such as
that found in the stomach.
The unique characteristics of DRcaps™
capsules can be employed to provide
efficient, targeted delivery for specific
applications and consumer groups:
Sensitive ingredients (e.g. probiotics,
enzymes) can be protected through to their
delivery in the intestine*.
Unpleasant tastes or smells of herbal or
mineral ingredients can be significantly
masked and digestive discomfort can be
reduced, improving the consumer experience
through increased comfort. In fact, in
consumer tests, DRcaps™ capsules were
preferred over tablets due to a better taste in
the mouth and very little aftertaste**.
DRcaps™ capsules may make new products
feasible where previously sensitivity issues
were too difficult, time-consuming and costly
to overcome.
General Specifications
Information
Capsugel manufactures two-piece DRcaps™
capsules from Hypromellose, that complies
with the requirements published in:
• The most current edition of the United
States Pharmacopoeia (USP) / National
Formulary (NF)
• The most current edition of the European
Pharmacopoeia (EP)
• The most current edition of the Japanese
Pharmacopoeia (JP)
• Specifications as published in the
European legislation for food additives.
• , for E 464 - HYDROXYPROPYL
METHYL CELLULOSE
• the most current Food Chemical Codex
(FCC).
• The most current FAO (JECFA
monograph).
In addition to Hypromellose, gellan gum is
used as gelling agent, that complies with the
requirements published in:
• the most current Food Chemical Codex
(FCC).
• Specifications as published in the
Japanese Standards for Food Additives.
• 21 Code of Federal Regulations
§172.665
• Specifications as published in the
European legislation for food additives
and amendments thereafter, for E 418 -
GELLAN GUM.
• the most current USP/NF monograph
Capsule shells may also contain opacifiers
and coloring agents.
Colorants
Capsugel applies, whenever the regulatory
status of the dye allows this, colorants and
pigments meeting the requirements of the
three European, US and Japan food and
pharmaceutical regulatory standards.
These standards include, where applicable:
• The most current edition of the
United States Pharmacopoeia (USP)
/ National Formulary (NF) / Codes of
Federal Regulations of the Food and
Drug Administration
• The most current edition of the
European Pharmacopoeia (EP) /
Specifications as published in the
European legislation for colorants as
food additives
• The most current edition of the
Japanese pharmacopoeia (JP)
/Japanese Pharmaceutical excipients
(JPE) / Specifications as published in
the Japanese legislation for colorants
as food additives and Pharmaceutical
Synthetic Dyes
Inks
The empty capsule can be printed with
product logo or company name. The
regulations governing printing inks are
constantly changing in the global market.
Regulations governing use of printing ink
colorants should be reviewed for end product
acceptance relative to product classification
(Pharmaceutical or Nutritional Supplement).
Only edible print inks are used by Capsugel
for printing.
Manufacturing Process
Capsugel capsules are manufactured under
controlled climate conditions by a dipping
process on high-capacity automatic
machines. Imprinting of the pre-closed
capsules, if desired by the customer, is
undertaken before the capsules are
transferred to final packaging. Due to the high
quality of its manufacturing conditions,
Capsugel, as a standard, does not use sulfur
dioxide or ethylene oxide for controlling
microbial growth. All of Capsugel’s empty
hard capsule manufacturing facilities are ISO
9001 certified. Copies of the certification
document are available upon request.
Capsugel manufactures the hard DRcaps™
capsules in accordance with the IPEC’s
(International Pharmaceutical Excipient
Council) Good Manufacturing Practices
Guide for Bulk Pharmaceutical Excipients.
Classification of Visual
Defects
Statistical Inspection
Capsugel hard DRcaps™ capsules are
statistically controlled to ensure batch
conformance to the quality parameters
described below. Both acceptance sampling
and process signal capturing can be used. An
acceptance sampling plan is used based on
the ANSI / ASQ Z 1.4-2008, “Sampling
Procedures and Tables for Inspection by
Attributes.” A normal inspection level, single
sampling plan is used.
Acceptable Quality Level (AQL)
The definition of AQL in ANSI / ASQ Z 1.4-
2008: “The AQL is the maximum percent
nonconforming (or the maximum number of
non conformities per hundred units) that, for
purposes of sampling inspection, can be
considered satisfactory as a process
average.”
• Major visual defects: defects which may
cause problems in the filling operation
such as non-opening, failure to rectify or
incorrect closure.
• Minor visual defects: defects which do
not affect the filling operation but detract
from the visual or cosmetic appearance
of the product.
