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Use of Kollicoat® Smartseal 30 D as a Moisture Barrier for Soft Gel Capsules

IP.com Disclosure Number: IPCOM000222823D
Publication Date: 2012-Oct-24
Document File: 3 page(s) / 135K

Publishing Venue

The IP.com Prior Art Database

Abstract

Soft gel capsules contain a hygroscopic active. The hydrophilic component of the fill on stability and storage takes up moisture until equilibrium is reached; as a result the capsules become leaky. To overcome this problem Kollicoat® Smartseal 30 D [KSS30D] added internally as a moisture barrier to the gelatin base. Gelatin base contains glycerin as a plasticizer and water added during preparation serves as a solvent to make a molten gelatin mass with a pourable viscosity at 60-70°C. The actives are injected in the liquid form and the capsules are hermetically sealed as one piece. After capsule formation, most of the water is removed by drying (dehumidification), leading to finished capsules with a moisture content of 10- 15 %.

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Use of Kollicoat Smartseal 30 D as a Moisture Barrier for Soft Gel Capsules

Background:

Soft gel capsules contain a hygroscopic active. The hydrophilic component of the fill on stability and storage takes up moisture until equilibrium is reached; as a result the capsules become leaky. To overcome this problem Kollicoat Smartseal 30 D [KSS30D] added internally as a moisture barrier to the gelatin base.

Gelatin base contains glycerin as a plasticizer and water added during preparation serves as a solvent to make a molten gelatin mass with a pourable viscosity at 60-700C. The actives are injected in the liquid form and the capsules are hermetically sealed as one piece. After capsule formation, most of the water is removed by drying (dehumidification), leading to finished capsules with a moisture content of 10- 15 %.

Approach:

Various films were prepared in the ratio of Gelatin base: Polymer content of KSS30D [9:1, 8:2, 6:4 and 1:1]. The prepared gelatin base was melted at 600C and KSS30D was added to the molten mass. Films were prepared manually using the film casting knife and dried at room temperature [25-300C].

Dispersion concentration used : 10% w/w Polymer concentration used: 3 % w/w Batch size : 5.5 Kg


1) Formula:

Sr. No.

Ingredients

Quantity %

Qty

Kg

1 Gelatin Base

90 5.0

2

Kollicoat Smartseal 30 D (Polymer Concentration)

 10 (3%)


0.5


(0.15)

Total

100.00 5.5


2) Gelatin Base Preparation:


a) Raw material preparation proportion: Gelatin: about 42%, Water: about 38%, Glycerin: about 20%, Color: quantity needed.


b) Melting temperature...