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Quali-V

®

HYPROMELLOSE CAPSULES FOR PHARMACEUTICALS

A multi-functional two-piece hard shell capsule manufactured from hypromellose using patented technology. Hypromellose is derived from plants. USA: Drug Master File

No. 12900 No. 14765 Canada: No. 2002-068

for Japanese plant for European plant for Japanese plant

Quali-V® Features ●

Good dissolution at acid pH

Non-brittle ◗ ◗

At low relative humidities (RHs) At reduced moisture contents

Chemically stable ◗

No cross-linking after ICH accelerated storage testing


Quali-V® meets the pharmaceutical requirements for two-piece hard capsules ●

Quali-V® capsules are made from plant derived hypromellose. This has been used extensively in oral solid dosage forms for many years. It is chemically stable and is compatible with most pharmaceutical materials.

Quali-V® capsules does not undergo cross-linking reactions like gelatin and assures encapsulated products with good dissolution.

Quali-V® capsules have the required strength and dimensions that enable them to be filled and packaged on automatic high-speed machines.

Quali-V® capsules meet the exacting requirements for a pharmaceutical-grade hard two-piece capsule.

Quali-V® Composition Polymer base

Hypromellose

USP, PhEur, JP

Gelling agent

Carrageenan

USNF, EEC, JPE

Gelling promoter

Potassium Chloride

USP, PhEur, JP

Additional benefits of Quali-V® capsules ●

Filling performance comparable to gelatin two-piece capsules.

Worldwide availability.

Patented composition and manufacturating process.

Registered DMF’s in USA & Canada.

Complies with requirements of JP, PhEur and USP/NF.

Available in a variety of sizes and colours.


Physical Stability Benefits Quali-V速 capsules have a lower moisture content, 4.0% to 6.0%, than gelatin capsules. They can be filled with many types of formulations: powders, pellets, tablets, semi-solids and non-aqueous liquids. Quali-V速 capsules maintain their physical stability when filled with hygroscopic materials or exposed to low humidity conditions. Quali-V速 capsules are particulary suited to use in dry powder inhalers because they can be cut and punctured cleanly without shedding particles. Moisture Content and Brittleness Brittleness Test (empty capsule)

Brittleness Test-Pressure Resistance Test (filled capsule)


Product Dissolution Quali-VÂŽ capsules have a patented formulation. Hypromellose solutions are converted into a gelling system by the addition of carrageenan and potassium chloride. They are manufactured by the same process as used for hard gelatin capsules. Carrageenan is soluble at low acid pHs giving good dissolution at a range of pH. Dissolution of acetaminophen in acid medium and water

Capsule fill formulation: Acetaminophen 50 mg Lactose 175 mg Croscarmellose 25 mg Fill weight: 250 mg (Size 1 capsule) Dissolution test method: Paddle at 50 rpm

Dissolution after ICH storage

Storage condition: 40 ÂşC, 75% RH, 6 months Capsule fill formulation: Acetaminophen 50 mg Lactose 175 mg Croscarmellose 25 mg Fill weight: 250 mg (Size 1 capsule) Dissolution test method: Paddle at 50 rpm

(Redrawn from data in S. Nagata et al., Poster, AAPS Annual Meeting, Denver, 2001)


Comparative Dissolution The composition of hypromellose capsules is dependent on the manufacturer: each has patented compositions. Quali-V® capsules are the only ones that use carrageenan. Carrageenan is the only gelling agent soluble at pH < 4. Quali-V® capsules made by our patented process have a solubility profile different to other manufacturers’ capsules. Hypromellose capsules from 3 different suppliers for the Japanese market were tested and the results are shown below. Dissolution of acetaminophen from hypromellose capsules in acid medium (pH 1.2)

Capsule fill formulation: Acetaminophen 60 mg Lactose 210 mg Croscarmellose 30 mg Fill weight: 300 mg (Size 0 capsule) Dissolution test method: Paddle at 50 rpm

Redrawn from data in Sakaeda, T., Nakamura, K., Tochio, S. and Nagata, S., Jpn J. Pharm. Health Care Sci., 28(6), 594-598 (2002)

In Vivo Performance In vivo studies have shown that Quali-V® and gelatin capsules have similar disintegration and release properties. The results showed that the two capsules have identical performances. Disintegration (Fasted state)1

Pharmacokinetic parameters (Fed state)2

Disintegration time (mean ± SD)

AUC 0-6h (µg/ml.h-1)

Cmax (µg/ml.h-1)

Tmax* (h)

Gelatin

7 ± 4 min

Gelatin

6.0 ± 0.7

1.88 ± 0.49

2.5

Quali-V®

9 ± 2 min

Quali-V®

5.8 ± 2.4

2.25 ± 0.66

1.5

1) Tuleu et al, Poster AAPS meeting. Baltimore, 2004. 2) Tuleu et al, Poster AAPS meeting. Nashville, 2005.

*Median


Volunteers: 8 healthy males Capsules: size 0, filled with Acetaminophen 250 mg, Lactose 200 mg, Croscarmellose 50 mg

Property comparison with gelatin capsules Quali-V速

Gelatin

4 - 6%

13 - 16%

Lower than gelatin

Low

No

Yes

Weak

Strong

Soluble

Insoluble

Moisture content Water vapour permeability Cross linking Static charging Solubility in water at room temperature

Compatibility with liquid-fill excipients Excipients

Results

Cotton seed oil

+

MCT

+

PEG400

-

Propylene glycol

-

Sesame oil

+

Soybean oil

+

Squalene

+

Triacetine

+

Triethyl acetate

+

+ Compatible - Incompatible Redrawn from data in S. Nagata et al, CRS Annual Meeting, 485 (2002).


Qualicaps hard shell capsule products ●

Qualicaps® Gelatin capsules

Qualicaps® PEG/Gelatin capsules

Quali-V® hypromellose capsules

Quali-V®-I hypromellose capsules

Patents on Quali-V® Japan

U.S.A.

Europe

JP Patents # 2.552.937

US Patents # 5.264.223

EP Patents # 0.592.130

JP Patents # 3.116.602

US Patents # 5.431.917

EP Patents # 0.714.656

JP Patents # 2.959.423

US Patents # 5.756.123

QUALICAPS GROUP Qualicaps Europe, S.A.

Qualicaps, Inc.

Qualicaps, Co., Ltd.

6505 Franz Warner Parkway Whitsett, NC 27377-9215 USA Tel.: +1 336 449 39 00 Fax: +1 336 449 33 33 e-mail: info@qualicaps.com

321-5, Ikezawacho Yamatokoriyama Nara 639-1032 Japan Tel.: +81 743 56 0651 Fax: +81 743 56 5113 e-mail: info@qualicaps.co.jp

www.qualicaps.com

Q 029/0-2006E

Calle de la Granja, 49 28108 Alcobendas, Madrid, Spain Tel.: +34 91 663 08 00 Fax: +34 91 663 08 30 e-mail: contact@qualicaps.es

Folleto de producto. Qualicaps Europe, S.A.  

Quali-V. Hypromellose Capsules for Pharmaceuticals

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