Hypromellose Capsules (HPMC Capsules) for Inhalation — QUALI-V®-I

Pharmaceutical capsules

Hypromellose Capsules (HPMC Capsules) for Inhalation

Hypromellose Capsules (HPMC Capsules) for Inhalation — QUALI-V®-I

A plant-derived hypromellose capsule designed for use with dry powder inhalers.

Hypromellose Capsules (HPMC Capsules) for Inhalation — QUALI-V®-I

Product Overview

  • Capsules for dry powder inhalers to deliver the active pharmaceutical ingredient into the lungs.
  • Hypromellose (HPMC) is 100% plant-based and QUALI-V®-I includes no animal-sourced raw materials whatsoever.
  • When the inhaler needle punctures the capsule, QUALI-V®-I capsules are less likely to produce fragments than gelatin capsules.
  • The amount of powder left on the capsule wall is reduced.
  • 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).

Capsule Colors

Capsule Colors

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

Capsule Sizes

Available in 6 sizes, from 00 to 4.

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

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

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
1 100,000
2 150,000
3 200,000
4 250,000

Test Data

Residual Powder Test

While gelatin capsules leave powder residue even at high inhalation flow rates, QUALI-V®-I capsules minimize powder residue at all flow rates, making
them ideal for inhalational APIs.

Residual Powder Test
Amount of formoterol remaining in the capsule (%)
Flow rate Gelatin
Capsules
HPMC
Capsules
QUALI-V®-I
30 L/min 1.9±0.4 1.1±0.2 <LOQ
60 L/min 2.1±0.2 1.1±0.3 <LOQ
100 L/min 2.3±0.5 <LOQ <LOQ
Test conditions

Inhaler: Axahaler®

Inhalation powder: 0.05% formoterol mixture

Fill weight: 24±1 mg

Documentation

We prepare accreditations and/or certifications for QUALI-V®-I. 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.