Hypromellose Capsules (HPMC Capsules) — QUALI-V®

Pharmaceutical capsules

Hypromellose Capsules (HPMC Capsules)

Hypromellose Capsules (HPMC Capsules) — QUALI-V®

The first hypromellose (HPMC) -based capsules, developed by Qualicaps®.

Hypromellose Capsules (HPMC Capsules) — QUALI-V®

Product Overview

  • Hypromellose (HPMC) is 100% plant-based and QUALI-V® includes no animal-sourced raw materials whatsoever.
  • Chemically stable and unaffected by drug contents.
  • Less affected by mechanical strength by air humidity and suitable for hygroscopic APIs.
  • Registered on Drug Master Files for the US and Canada, and on Center for Drug Evaluation in China.
  • Manufactured in a validated continuous production environment in compliance with Good Manufacturing Practice (GMP).
  • High-quality raw materials in conformity to the JP, the EP, and the USP/NF for specifications are used.
  • Free of preservative and allergen (28 raw materials identified as allergens in Japan).
  • It is possible to fill with a combination of two or more types of preparations, such as solid, oily liquid, and semi-solid preparations (oily liquid and semi-solid preparations need the band sealing).

Capsule Colors

Capsule Colors

Hard capsules have the advantage to enhance their distinguishability.
Various capsule colors can be made upon request.

Capsule Printing

More than 90% pharmaceutical capsules made in Qualicaps® are imprinted to enhance distinguishability.

Two imprinting methods are available:
・Offset printing with various color ink
・UV lazer printing with no ink : Qualicaps®'s own technology

Offset printing

Offset printing uses edible ink,
in which various colors are available.

Offset printing
UV lazer printing

UV lazer printing technology utilizes the color change of titanium oxide by UV irradiation.
UV lazer can print fine design to capsules.

UV lazer printing
Offset printing UV lazer printing
Color Various Gray
Fineness Good Excellent

Capsule Sizes

Available in 7 sizes, from 00 to 5.

In addition, please contact us for inquiries about the special size.

Capsule Sizes
Size (♯) 00 0 1 2 3 4 5
Volume (mL) 0.93 0.68 0.49 0.37 0.28 0.21 0.13

Also available in size 9 for small animal use.

Capsules for small animal use.
Capsules for small animal use.
Capsule sizes (♯) 9
Capacity 25 μL
Colors Cap: Clear blue
Body: Clear

Packaging Quantities (number included)

The standard numbers of capsules packed in each case for outside of Japan are as follows.

Capsule size (♯) Standard quantities
00 70,000
0 90,000
1 Transparent capsules 100,000
Opaque capsules 125,000
2 150,000
3 200,000
4 250,000
5 400,000

Test Data

Dissolution Test

No difference in the rate of dissolution of QUALI-V® in water, 1st fluid for dissolution test (simulated gastric fluid), or 2nd fluid for dissolution test
(simulated intestinal fluid).

Test Data
n=6
Source: In-house data
Test conditions

Capsule size: ♯3

Apparatus: Paddle method, 50 rpm, UV detection

Dissolution media: water, 1st fluid for dissolution test, or 2nd fluid for dissolution test, 900 mL each

Capsule fill formulation: 20% acetaminophen mixture

Fill weight: 200 mg

Brittleness Test

Capsules are evaluated by pressing 100 capsules at 60 PSI for 15 seconds in a dedicated testing apparatus and checking for broken capsules.

QUALI-V® capsules are more resistant to brittleness than QUALI-G™ capsules when compared at the same moisture content, which is an advantage when handling hygroscopic APIs.

Relationship with Relative humidity
Relationship with Relative humidity
n=100
Source: In-house data
Relationship with Capsule moisture content
Relationship with Capsule moisture content
n=100
Source: In-house data
Test conditions

Temperature: 25.0±3.0 ℃

Documentation

We prepare accreditations and/or certifications for QUALI-V®. For further reference, please contact us for further information.

Kosher Certification (Copy)
Residual Solvents Statement BSE/TSE Statement Elemental Impurities Statement
GMO Statement Allergen Statement Melamine Statement
Nitrosamines Statement Titanium Oxide Statement Gluten Statement
Irradiation Statement
SDS Capsule Specifications Flow of Manufacturing Capsules
Test Methods Capsule Theoretical Formula COA Sample

Additionally, Qualicaps® received ISO9001 and ISO14001 certification.
See ″ISO Management″ for further details.

Related Products

Trademark

QUALI-V is a registered trademark of Qualicaps in China, India, US, Canada, EU, Swiss, and UK.

Inquiries / Downloads

For inquiries about capsules or equipment, or to download reference materials, click on the links below.