Ready-mix film coating systems for solid oral dosage forms
Aarav Pharma Chem researches, manufactures and markets the Flora Coat range of aqueous and solvent-based coating systems for the pharmaceutical, nutraceutical, veterinary, herbal and ayurvedic industries.
Flora Coat AFC
Aqueous- Reconstitution level16%
- Weight gain1.75–2.0%
- Bed temperature38–42 °C
Coating science, packed into a single ready-mix drum
Aarav Pharma Chem is one of the fastest growing companies engaged in the business of research, manufacturing and marketing of Flora Coat ready-mix film coating systems for the pharmaceutical, nutraceutical, veterinary, herbal and ayurvedic industry. We are committed to on-time supply and consistent quality.
We manufacture ready-to-use film coating material for solid oral dosage forms, covering normal film coating, functional coating and speciality products. Our head office is at Ahmedabad, one of the most important industrial centres in the western part of India.
Research led
Grades developed in-house for regular, functional and speciality coating needs.
On-time supply
Committed delivery schedules so your coating suite never waits on material.
Consistent quality
Batch-to-batch reproducibility in colour, film character and dispersion behaviour.
Expert advice
Our team helps you select the right grade and dial in the process parameters.
The full Flora Coat range
Aarav Pharma Chem manufactures and supplies the full range of film coating material under the brand name Flora Coat, for regular film coating and functional coating. Depending on the requirement, customers can take help of our expert advice for choosing the right product for their application.
Flora Coat for regular film coating
Flora Coat has a wide range of products available for conventional film coating of solid oral dosage forms, in both aqueous and non-aqueous (solvent) systems. Both grades are HPMC based and applied at a 1.5–2.5% use level.
Product overview
| Product | Usage | Use level | Based on |
|---|---|---|---|
| Flora Coat AFC | Ready-mix material for film coating with aqueous system | 1.5–2.5% | HPMC |
| Flora Coat NFC | Ready-mix material for film coating with non-aqueous (solvent) system | 1.5–2.5% | HPMC |
Reconstitution
Example for tablet batch size: 100 kg| Product | Description | Recon. level | Flora Coat req. | Water | IPA | MDC |
|---|---|---|---|---|---|---|
| Flora Coat AFC | Aqueous | 16% | 2.0 kg | 18.0 kg | n/a | n/a |
| Flora Coat NFC | Solvent | 5% | 2.0 kg | n/a | 15.2 kg | 22.8 kg |
* Depends on coating facilities at customer’s premises and the product to be coated.
Suggested process parameters
Conventional pan vs. auto coater| Parameter | AFC · Conventional | AFC · Auto coater | NFC · Conventional | NFC · Auto coater |
|---|---|---|---|---|
| Coating equip. | 36″ | 46″ | 36″ | 48″ |
| Solvent system | Aqueous | Aqueous | Organic | Organic |
| Pan speed (rpm) | 8–12 | 3–5 | 8–12 | 3–5 |
| Baffles | 4–6 | 6–8 | 4–6 | 6–8 |
| Tablet charge (kg) | 40–50 | 100–130 | 40–50 | 100–130 |
| Bed temp. | 38–42 °C | 38–42 °C | 35–40 °C | 35–40 °C |
| Spray nozzle | 1.2 mm | 1.2–1.5 mm | 1.2 mm | 1.2–1.5 mm |
| No. of spray guns | 1 | 2–3 | 1 | 2–3 |
| Air pressure | 3–3.5 bar | 3–3.5 bar | 2.5–3.5 bar | 2.5–3.5 bar |
| Spray procedure | Continue | Continue | Continue | Continue |
| Spray rate (gm/min) | 50–60 | 120–140 | 100–150 | 300–400 |
| Inlet air temp. | 65–75 °C | 65–75 °C | 60–65 °C | 60–65 °C |
| Drying air volume (cfm) | 400–500 | 1500–2000 | 400–500 | 1500–2000 |
| Weight gain % | 1.75–2.0 | 1.8–2.0 | 1.75–2.0 | 1.75–2.0 |
Flora Coat for enteric coating
Flora Coat has a wide range of products for enteric coating systems suitable for various pharmaceutical solid oral dosage forms (tablets, drug-loaded pellets, herbal granules, ayurvedic and nutraceuticals) for protection in the gastric medium. Flora Coat is also available for use in aqueous enteric coating for soft gel capsules and targeted colonic delivery.
Flora Coat E Aq. is a methacrylic acid copolymer type “C” based ready-mix powder. Its film is insoluble in gastric fluids and natural juice, but freely soluble in the intestinal tract at pH 5.5 and above by formation of soluble salts of electrolytes present in the GI tract.
Product overview
| Product | Usage | Use level | Based on |
|---|---|---|---|
| Flora Coat EN | Ready-mix material for enteric coating with solvent system | 6.0–7.0% | Methacrylic acid co-polymer type “A” |
| Flora Coat REC | Ready-mix material for enteric coating with solvent system | 7.0–9.0% | Cellulose acetate phthalate |
| Flora Coat E Aq. | Ready-mix material for enteric coating with aqueous system | 8.0–9.0% | Methacrylic acid co-polymer type “C” |
Reconstitution
Example for tablet batch size: 100 kg| Product | Description | Recon. level | Flora Coat req. | Water | IPA | MDC |
|---|---|---|---|---|---|---|
| Flora Coat E Aq. | Aqueous | 12–15% | 9.0 kg | 66–51 kg | n/a | n/a |
| Flora Coat EN | Solvent | 10% | 7.0 kg | n/a | 63.0 kg / 44.0 kg | 19.0 kg (+ acetone) |
| Flora Coat REC | Solvent | 5% | 8.0 kg | n/a | 112.0 kg | 28.0 kg |
* Depends on coating facilities at customer’s premises and the product to be coated.
Suggested process parameters
Conventional pan vs. auto coater| Parameter | E Aq. · Conv. | E Aq. · Auto | EN · Conv. | EN · Auto | REC · Conv. | REC · Auto |
|---|---|---|---|---|---|---|
| Coating equip. | 36″ | 48″ | 36″ | 48″ | 36″ | 48″ |
| Solvent system | Aqueous | Aqueous | Organic | Organic | Organic | Organic |
| Pan speed (rpm) | 8–12 | 3–5 | 8–12 | 3–5 | 8–12 | 3–5 |
| Baffles | 4–6 | 6–8 | 4–6 | 6–8 | 4–6 | 6–8 |
| Tablet charge (kg) | 40–50 | 100–130 | 40–50 | 100–130 | 40–50 | 100–130 |
| Bed temp. | 35–40 °C | 35–40 °C | 30–35 °C | 30–35 °C | 38–40 °C | 38–40 °C |
| Spray nozzle | 1.2 mm | 1.2–1.5 mm | 1.2 mm | 1.2–1.5 mm | 1.2 mm | 1.2–1.5 mm |
| No. of spray guns | 1 | 2–3 | 1 | 2–3 | 1 | 2–3 |
| Air pressure | 2–2.5 bar | 2–2.5 bar | 1.5–2.5 bar | 1.5–2.5 bar | 2.5–3.5 bar | 2.5–3.5 bar |
| Spray procedure | Continue | Continue | Continue | Continue | Continue | Continue |
| Spray rate (gm/min) | 50–60 | 120–150 | 60–75 | 200–300 | 100–140 | 300–350 |
| Inlet air temp. | 65–75 °C | 65–75 °C | 45–50 °C | 45–50 °C | 60–65 °C | 60–65 °C |
| Drying air volume (cfm) | 400–500 | 1500–2000 | 400–500 | 1500–2000 | 400–500 | 1500–2000 |
| Weight gain % | 8.0–9.0 | 8.0–9.0 | 6.75–7.0 | 6.75–7.0 | 7.5–8.0 | 7.5–8.0 |
Flora Coat MFC for moisture barrier coating
Aarav Pharma Chem has developed products for excellent moisture barrier coating of moisture sensitive drugs. Flora Coat MFC provides good stability and protection for hygroscopic drugs.
Typical applications
| Ayurvedic, herbal & unani drugs | Moisture-sensitive botanical actives |
|---|---|
| Amitriptyline HCl, Atorvastatin | Stability-critical APIs |
| Ethambutol | Hygroscopic API |
| Multivitamin, Ranitidine HCl | And all other hygroscopic drugs |
Product overview
| Product | Usage | Use level | Based on |
|---|---|---|---|
| Flora Coat MFC | Ready-mix material for moisture barrier coating of moisture sensitive products | 3.0–4.0% | HPMC + ethyl cellulose |
Flora Coat MFC at a glance
| Weight gain | 3.0–4.0% |
|---|---|
| Addition of colorants | Ready to use |
| Reconstitution level | 5.0% organic (IPA 40% + MDC 60%) |
Easy to prepare: mix for 45 minutes and coat
Flora Coat systems are very easy to prepare. Add the Flora Coat powder to solvent or water as described below and mix for 45 minutes with a propeller stirrer.
Equipment
- S.S. vessel with a capacity 25% more than the total suspension being prepared. Vessel height should be around 1.25× its diameter.
- A variable speed propeller stirrer with blade diameter nearly ⅓ of the diameter of the S.S. vessel.
Precautions
- The usage of a high speed stirrer or homogenizer is not recommended.
- The suspension should not be passed through a colloidal mill for Flora Coat E Aq.
- The suspension may need gentle stirring during the coating operation to maintain homogeneity during spray.
- The suspension thus prepared should be used within 24 hours to avoid microbial contamination.
Weigh the Flora Coat
Weigh the required quantity of Flora Coat powder for your batch.
Charge the water
Take the required quantity of water in the S.S. vessel.
Form a vortex and add powder
Stir with the propeller stirrer to form a vortex. Add the quantity of Flora Coat into the vortex and stir for 5 minutes.
Reduce speed, continue 40 minutes
Reduce the speed of the stirrer and continue mixing for a further 40 minutes.
Sieve and coat
Pass the solution through a 150 micron opening sieve and use for coating.
Weigh the Flora Coat
Weigh the required quantity of Flora Coat powder for your batch.
Charge the IPA
Take the required quantity of IPA in the S.S. vessel.
Form a vortex and add powder
Stir with the propeller stirrer to form a vortex. Add the quantity of Flora Coat into the vortex and stir for 5 minutes.
Add methylene dichloride
Add the required quantity of methylene dichloride and continue mixing for 40 minutes.
Sieve and coat
Pass the solution through a 150 micron opening sieve and use for coating.
Fix it at the pan, not in the lab
Common coating defects and the process checks that resolve them.
- Check dilution.
- Check drying air temperature (optimum temp. 50–60 °C).
- Check spray rate. Reduce spray rate if necessary.
- Check atomizing air pressure. If atomizing air pressure is less than 80 psi, larger drops are formed, resulting in increased drying time and surface roughness.
- Check side air flow. Excessive side air flow will cause premature drying of spray, resulting in flying of coating material particles.
- Check distance of the spray gun from the tablet bed surface. Take the gun slightly closer to the bed.
- Check drying air temperature. Higher drying air temperature will cause premature drying of spray, causing deposition of particles on the tablet surface.
- If side air flow is high, the coating material can dry up before reaching the tablet surface. The dried particles cause roughness by sticking to the surface.
- High viscosity solution can also give a rough surface by creating hindrance in proper spraying. Check dilution.
- Check friability of core tablets.
- Check distance of the spray gun from the tablet bed. Do not keep the gun very close to the bed surface or very far from it. A distance of 9″ to 12″ is ideal.
- Check drying air temperature is at the optimum level mentioned above.
- Increase spray rate if necessary. Excessive fine spray can also cause premature drying.
- Check atomizing air pressure. Very high atomization can result in premature drying.
- Check spray rate. Reduce spray rate if necessary.
- Check whether the coating pan surface has excessive coating solution on it. Excess solution on the pan gets wet, causing tablets to stick to the pan surface; on drying the material peels off the tablet surface resulting in white patches. Clean the pan surface, then continue coating.
- Check side air flow and dilution.
- Ensure good rolling of tablets in the pan. Improper rolling or sliding causes excessive rubbing at the bottom of the bed and excessive wetting on top, which also develops patches.
- This is due to inefficient rolling of the tablets in the pan. To get uniform distribution of colour, ensure good rolling of tablets. Use an additional baffle if necessary.
- Spreading the solution spray by opening the side air flow will aid in improving distribution.
Not sure which grade fits your product?
Tell us your dosage form, API sensitivity and coating equipment. Our team will recommend the right Flora Coat grade and starting process parameters.
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Head office
B-701, Victory Sunrise, Opp. Vishwas City 7, near Satyamev Vista,
Off Sarkhej–Gandhinagar Highway, Gota, Ahmedabad, Gujarat 382481
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