| Size (♯) | 00 | 0 | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|---|---|
| Volume (mL) | 0.93 | 0.68 | 0.49 | 0.37 | 0.28 | 0.21 | 0.13 |
Gelatin Capsules Containing PEG — QUALI-G™-PEG
Pharmaceutical capsules
Gelatin Capsules Containing PEG
Gelatin capsules with improved strength against brittleness.
Product Overview
- Gelatin capsules to which polyethylene glycol (PEG) 4000 equal to 5 wt% is added as a plasticizer.
- Mechanical strength of this type of gelatin capsules under low-moisture conditions is much greater than that of standard gelatin capsules.
- Dissolution property of this type of gelatin capsules is the same as that of standard gelatin capsules.
- Registered on Drug Master Files for the US and Canada.
- 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.
- Preservative-free.
- Suited to filling with hygroscopic APIs.
- 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
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.
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.
| 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.
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
QUALI-G™-PEG capsules, as same as QUALI-G™, have excellent dissolution properties, with not less than 80% of the capsule contents released within 5 minutes.
Source: In-house data
Test conditions
Capsule size: ♯3
Apparatus: Paddle method, 50 rpm, UV detection
Dissolution medium: water, 900 mL
Capsule fill formulation: 20% acetaminophen mixture
Fill weight: 150 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-G™-PEG 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
Source: In-house data
Relationship with Capsule moisture content
Source: In-house data
Test conditions
Temperature: 25.0±3.0 ℃
Documentation
We prepare accreditations and/or certifications for QUALI-G™-PEG. For further reference, please contact us for further information.
| 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.
