| Size (♯) | 00 | 0 | 1 | 2 | 3 | 4 |
|---|---|---|---|---|---|---|
| Volume (mL) | 0.93 | 0.68 | 0.49 | 0.37 | 0.28 | 0.21 |
Hypromellose Capsules (HPMC Capsules) for Inhalation — QUALI-V®-I
Pharmaceutical capsules
Hypromellose Capsules (HPMC Capsules) for Inhalation
A plant-derived hypromellose capsule designed for use with dry powder inhalers.
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 USP/NF, and the Ph. Eur. for specifications are used.
- Free of preservative and allergen (28 raw materials identified as allergens in Japan).
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.
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.
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, Switzerland, and UK.