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Development and Optimization of Instanute Coating Formulation containing Calcium Carbonate as an opacifier
Suresh Pareek, Sanjay Negi, Dario Luini,Rupali Bhadale,Vaishali Jamnik
Ideal Cures Private Limited QR Code PURPOSE
Titanium dioxide (TiO2) is the most widely used white pigment in
pharmaceutical/Nutraceutical coating formulations. It has high brightness
and a very high refractive index. Apart from producing a white colour in
liquids, paste or as coating on solids, TiO2 is also an effective opacifier,
making substances more opaque. However there has been information
that the white pigment titanium dioxide (TiO2) is a potential carcinogen.
Hence many pharmaceutical companies are avoiding use of titanium di
oxide in their pharmaceutical and nutraceutical products .Calcium
carbonate is an alternative opacifier which is non-toxic, economical and
safe for consumption.
CONCLUSION The opacity of Instanute IR coatings containing calcium carbonate was assessed and found good. Instanute IR formulations containing calcium carbonate provide a good alternative to typical coatings containing titanium di-oxide for Nutraceuticals exhibiting good hiding and coloring properties.
RESULTS
METHOD
• Instanute IR, a ready formulated coating system comprising of
calcium carbonate as opacifier, was used in this study with DM water
for coating suspension preparation.
• An experimental plan with varied concentration of calcium carbonate
(15% and 25%), were used.
• Coating suspension was prepared with 15% solids content.
Viscosities of suspensions were measured using a Brookfield
viscometer.
• Coating trials were executed in a conventional coating pan using
yellow core tablets till 5% weight gain. The critical coating process
parameters i.e. product bed temperature, spray rate, pan rpm and %
weight gain were optimized.
• Instanute IR film coating opacity was determined by measuring the
contrast ratio of the coatings on opacity chart using a Data color® 500
machine.
OBJECTIVE
To develop an optimized Instanute ready-mix formulation containing
Calcium Carbonate as an alternative opacifier instead of Titanium Di
Oxide.
FUNDING / GRANTS / ENCORE / REFERENCE OR OTHER USE
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CONTACT INFORMATION: [email protected]/+(91)-22-42688700 .
W1030-10-077
METHOD
Table No. 1. Core Tablets And Coating Formulation Details Table No.2. Coating Process Parameters
A)Placebo Tablet Details
Placebo Tablet dimensions 12 mm round Biconvex tablets, plain on both sides.
B) Coating Formulation Details
Product Name INSTANUTE IR
Trial I Trial II
Color White White
Calcium carbonate (%) 15 25
Solids Level (%w/w) 15 15
Sr. No. Parameter Trial - I Trial - II
1 Coater Type Conventional Conventional
2 Pan size 4” 4”
3 Lot Size (gm) 75 75
4 Inlet Temp. (°C) 55 55
5 Product Bed Temp. (°C) 38 to 42 38 to 42
6 Spray rate (gm/min) 0.5 0.5
Sr.NO. Formulation Opacity Value
1 Instanute IR containing TiO2 97.28
2 Trial- I 85.55
3 Trial- II 93.64
Instanute IR film coating opacity determined by measuring the contrast ratio of coatings on black and white backgrounds using a Data color® 500 machine was found to be adequate compared to the film containing Titanium dioxide. (Table no. 3)
Figure 1 (Coated Tablets)
Table no.3. Opacity Values of formulation
