Ideal Cures Instaglow

Identification & Functionality

Pharma & Nutraceuticals Functions

Polishing Agent

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Formulation & Processing Aids

Typical Constituents

HPMC; PEG 6000; Glycerine; PVA; Glidant.

Features & Benefits

Features

• Dry powder system for reconstitution.

• Complete coating formulation minus solvent.

• Compatible with aqueous, organic and hydro alcoholic solvent systems.

• Imparts high gloss to solid dosage forms.

• Acts as a sealant for uncoated tablets.

• Can be applied in a wide range of equipment designs and sizes from most manufacturers.

Benefits

• Process time savings from rapid coating suspension manufacture.

• Cost savings in inventory and inventory management.

• Process and equipment flexibility.

• Enhances product appearance.

• Improves bulk tablet flow rates and productivity particularly in blister packing lines.

• Reduces dust generation during bulk tablet handling.

• Promotes a cleaner safer environment, with easy clean-down and product changeover.

• Easy scale-up and transfer to different equipment types or manufacturing sites.

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Healthcare & Pharma — Pharmaceutical Manufacturing

Pharmaceutical Processing

Manufacturing Technology

Tablet Coating

Equipment / Accessories

• Variable-speed mechanical stirrer

• Mixing Vessel

Properties

Physical Form

Powder,

Solid

Regulatory & Compliance

Regulatory Information

All products are checked for the regulatory compliance of all ingredients in the target countries and market segments of sale. This determination is made at the time the initial formulation is established, based on customer-supplied information. If market countries and/or segments are extended once the formulation has been established, customers are encouraged to contact us to ensure that regulatory compliance is not compromised.

Technical Details & Test Data

Recommended Solvent System and Reconstitution Level

• Purified water at up to 7% w/w solids

• Organic: IPA 35% + MDC 65% w/w at up to 5% solids

• Hydro-alcoholic: Water 15% + IPA 85% w/w at up to 5% solids

Calculation of Instaglow and Solvent Quantities

• Determine the quantities of Instaglow (7% w/w solids) and water required based on the quantity of tablets to be coated and the target coating weight gain. e.g.: For coating 1.0 kg of tablets to 0.2% wt. gain, weigh 2.2 g Instaglow and 29.2 gm purified water at room temperature (includes 10% overage for losses)

• Determine the quantities of Instaglow (5% w/w solids) and IPA 35% + MDC 65% required based on the quantity of tablets to be coated and the target coating weight gain. e.g.: For coating 1.0 kg of tablets to 0.2% wt. gain, weigh 2.2 g Instaglow and 41.8 gm IPA 35%+ MDC 65% at room temperature (includes 10% overage for losses)

• Determine the quantities of Instaglow (5% w/w solids) and Water 15% + IPA 85% required based on the quantity of tablets to be coated and the target coating weight gain. e.g.: For coating 1.0 kg of tablets to 0.2% wt. gain, weigh 2.2 g Instaglow and 41.8 gm Water 15% + IPA 85% at room temperature (includes 10% overage for losses)

Reconstitution Process

• Instaglow (Aqueous)

  • Add the weighed quantity of water to a mixing vessel.

  • Using a mechanical stirrer, stir the purified water to form a vortex.

  • Add required quantity of Instaglow to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of Instaglow has been added, reduce the stirrer speed to eliminate the vortex. (Fig. 2) Continue mixing for 45 minutes.

• Instaglow (Organic)

  • Add the weighed quantity of organic solvent to a mixing vessel.

  • Using a mechanical stirrer, stir the organic solvent to form a vortex.

  • Add required quantity of Instaglow to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of Instaglow has been added, reduce the stirrer speed to eliminate the vortex. (Fig. 3) Continue mixing for 45 minutes.

• Instaglow (hydro alcoholic)

  • Add the weighed quantity of hydro alcoholic solvent to a mixing vessel.

  • Using a mechanical stirrer, stir the hydro alcoholic solvent to form a vortex.

  • Add required quantity of Instaglow to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of Instaglow has been added, reduce the stirrer speed to eliminate the vortex. (Fig. 4) Continue mixing for 45 minutes.

Recommended Process Conditions

	Side-Vented (Fully Perforated) Pans	Conventional (Non Perforated) Pans
Pan Diameter (inch)	24-60	12-36
Tablet Load (kg)	10-300	0.5-50
Weight Gain (%)	2.0-3.0%
Number of Guns	1-6	1
Liquid Nozzle diameter (mm)	1.0-1.2
Atomising Air Pressure (bar)	2.5-3.5
Pattern Air Pressure	To achieve maximum uniform bed coverage
Tablet Bed Temperature, Aqueous (°C)	40-45
Tablet Bed Temperature, Organic (°C)	34-38
Tablet Bed Temperature, Hydro- Alcoholic (°C)	36-40
Inlet Air Temperature (°C)	Set to achieve required product bed temperature
Suspension Spray Rate	Set to achieve required product bed temperature
Exhaust Air Volume	To maintain slight negative pressure in pan
Pan Speed	Minimum for steady tablet flow through spray zone

Tablet bed temperature offers the most effective way of controlling the coating process. Where this measurement is unavailable, exhaust temperature may be substituted. However, the relationship between the two measurements is complex and depends on several factors such as pan load, pan depression, pan design and airflow rate. Indicated exhaust temperature may be above or below the true bed temperature. It is recommended that the relationship between the two measurements is calibrated.