Questions
Frequently asked questions
64 answers in one place, from what we do and do not sell through to how a specific grade runs on your coater.
About the company and what we supply
Do you supply tablet coating machines?
No. We make the material that goes into the coater, not the coater itself. If you are looking for a coating pan or an auto coater, you need an equipment manufacturer. If you have the machine and need the film that goes onto the tablet, that is us.
Do you supply nutraceutical and ayurvedic manufacturers?
Yes. The grades are the same, the regulator is not. Pharmaceutical customers work under the Drugs and Cosmetics Act, nutraceutical customers under FSSAI, and ASU manufacturers under Schedule T. Responsibility for the approvals your finished product needs stays with you, and we supply the documentation to support them.
What is a ready-mix tablet coating material?
A single blend that you disperse in water or in solvent and spray. Everything the film needs is already in the blend, so your plant is not weighing and mixing individual polymers and pigments before every batch, and the film you qualified is the film you get on the next order.
Do you match a shade to our existing tablet?
Yes. Shade is matched against a reference sample you send us rather than against a shade card, and it is confirmed before the batch is released. That way a repeat order reproduces the finish you approved.
Can we get a trial quantity before committing to an order?
Yes. Trial quantities go out with the application parameters for your pan size, so the first batch is not a guess. Trial material is supplied for evaluation, and the parameters are then confirmed against your batch size during scale-up.
Which of your grades need a solvent process?
The metallic and pearl series, the moisture barrier grades, the sugar film coat and the non-aqueous film coats all run on solvent. The aqueous film coats and ECM-RP348 run on water. UZ1 runs on either, which is why units with mixed lines hold it.
Where are you located and who do you supply?
Our works are at Plot No. 30, Industrial Area Tahliwal, Tehsil Haroli, Distt. Una 174507, Himachal Pradesh, inside the pharmaceutical belt running through Baddi and Barotiwala. We supply solid dosage manufacturers across India.
Choosing a grade
How do I choose between the enteric grades?
By the active and by the polymer your filing names. ECM-RP347 is non-aqueous methacrylic for the Pantoprazole group, ECM-RP348 is the aqueous methacrylic route for Diclofenac and Serratiopeptidase, EC714 covers the same two actives on a CAP base, ECPT5 is phthalate base for Duloxetine, and ECMS is a second bond for Mesalamine.
Do all grades run on the same parameters?
There are two bands. Film, seal, sugar, metallic, moisture barrier and sustained release grades run the film coating band, which is 35 to 40 degrees at the bed for aqueous and 30 to 35 for non-aqueous. Every enteric grade runs cooler, at 30 to 32 degrees with a 45 to 50 degree inlet, because a hot bed costs you gastro resistance.
What if the grade we need is not listed here?
It can be developed against your specification. Send the core composition, the shade reference and the coating equipment details, and we formulate against them rather than fitting you to an existing code.
Which grades are blended rather than coated?
RT-114, RT314 and HR100 go in at the blending stage rather than through a coater. The taste mask goes into the suspension formulation, the dissolution enhancer corrects disintegration time and dissolution, and the hygroscopic adsorbent is added ahead of compression.
Quality and documentation
Do you accommodate customer audits?
Yes. We accommodate customer audits of the Tahliwal works. Write to us with what your quality team needs to see and we will arrange it.
Can we reference your DMF in our filing?
Once the file is issued. The U.S. Drug Master File is applied for, and when it is in place your regulatory team can cite the file rather than duplicating our data in your own submission.
What documentation comes with a supply?
The technical and regulatory documentation your filings need. Tell us what your quality team requires at the enquiry stage so it ships with the material rather than being chased afterwards.
Questions about a specific grade
ECM-RP347 · Enteric coat, methacrylic base, non-aqueous
Does ECM-RP347 need a seal coat underneath?
Yes for the Pantoprazole group. Lay SC-401 down first as a transparent seal, then apply the enteric film over it. The seal isolates the acid labile core from the enteric polymer and gives the functional layer an even surface to build on.
Can it run on a 24 inch conventional coater?
Yes. At 24 inch the pan runs at 10 to 14 rpm with a 3 to 5 kg charge. Hold the bed at 30 to 32 degrees against a 45 to 50 degree inlet, the same as every other grade in the enteric range.
Is it aqueous or solvent based?
Solvent based. It is a methacrylic film applied from a non-aqueous system, so solvent handling and area classification apply to the enteric stage. Where your core allows a water base process, ECM-RP348 is the aqueous equivalent.
ECM-RP348 · Enteric coat, methacrylic base, aqueous
Which actives is ECM-RP348 formulated for?
Diclofenac and Serratiopeptidase enteric tablets. It is a methacrylic base film, the same polymer family as ECM-RP347, applied from water rather than solvent.
How does it differ from EC714?
Both are formulated for the same actives by different polymer routes. ECM-RP348 is methacrylic, EC714 is cellulose acetate phthalate. Choose EC714 where a CAP film is named in your filing, otherwise the aqueous methacrylic route is simpler to run.
Is the aqueous route slower?
The stage takes longer. Bed temperature still has to sit at 30 to 32 degrees to protect the polymer film, and drying water at that temperature is slower than drying solvent, so plan for a longer stage rather than pushing the spray rate.
ECPT5 · Enteric coat, phthalate base
What is ECPT5 formulated for?
Duloxetine enteric tablets. Release is governed by a phthalate base polymer rather than a methacrylic film, which is why it is a separate grade rather than a shade of the methacrylic range.
Can a profile from another enteric grade be carried over?
No. Because the polymer differs, confirm both the acid stage and the buffer stage on the first trial batch instead of carrying over a dissolution profile from a methacrylic enteric product.
ECMS · Enteric coat, methacrylic second bond
Why is ECMS described as a second bond?
The second bond holds release until a defined point in the intestinal tract, which is what Mesalamine needs. A standard gastro resistant film releases too early for that product.
How do we confirm the coat is right?
By dissolution testing rather than appearance. A Mesalamine coat that looks correct can still release at the wrong point, so the dissolution profile is the acceptance criterion.
EC714 · Enteric coat, CAP base
When should EC714 be chosen over ECM-RP348?
When a CAP film is specified in your filing. Both grades are formulated for Diclofenac and Serratiopeptidase enteric tablets, but EC714 builds the film on cellulose acetate phthalate rather than a methacrylic polymer.
What temperature does it run at?
The standard enteric band. Bed at 30 to 32 degrees, inlet at 45 to 50, across every pan size from 12 to 48 inch.
CVS-101 · Moisture barrier for Amoxycillin and Clavulanate
Is CVS-101 suitable for Amoxycillin and Clavulanate tablets?
That is what it was developed for. It is a solvent base extra white moisture barrier built for the combination, where water ingress during and after coating drives degradation.
Does the coating alone protect the tablet?
No. The barrier film protects the core inside the pack, it does not repair moisture already picked up. Plan the stage so coated tablets move to blistering without a long open hold.
PA-Wt10 · Extra white film coat for plain Amoxycillin
How does PA-Wt10 differ from CVS-101?
PA-Wt10 is for plain Amoxycillin and other dissolution critical tablets. CVS-101 is built for the Amoxycillin and Clavulanate combination, which carries a harder moisture problem.
What should be checked at the end of a run?
Dissolution, not only cover and gloss. On these cores dissolution is the constraint, so a batch that looks right can still fail the specification.
MB 31RP · Moisture barrier for multivitamin and ferrous tablets
Which products is MB 31RP used on?
Multivitamin and Ferrous group tablets. Both are hygroscopic before they reach the coater, so the barrier film carries part of the shelf life rather than only improving appearance.
What is the first sign the barrier is too thin?
Colour drift on coated tablets through the early stability pulls. Watch colour before you watch assay.
AQ-ZWt10 · Aqueous film coat, extra white
Why use AQ-ZWt10 instead of AQ-Z Wb?
Opacity for a given build-up. On Calcium and Azithromycin cores the core colour bleeds through a conventional white film, and the Wt10 grade reaches full cover earlier.
Does it run differently?
No. It runs on the same aqueous band, 35 to 40 degrees at the bed against a 75 to 80 degree inlet. You simply stop earlier, before the film starts to bridge the break line.
SC-401 · Transparent seal coat and pre-coat
When is a seal coat needed before an enteric layer?
On acid labile cores, the Pantoprazole group in particular. SC-401 isolates the core from the enteric polymer and gives the functional film an even surface to build on.
How thick should the seal layer be?
Thin. Its job is to isolate, not to cover. Where the sub-coat also has to hide a dark or mottled core, SC-501 is the grade to use instead.
HR100 · Hygroscopic adsorbent material
Which actives does HR100 work on?
Sodium Valproate, L-Carnitine, Valproate Sodium and other hygroscopic drugs that pick up moisture and create problems during compression and afterwards.
Is it a coating?
No. It is added at the blending stage ahead of compression. Where a hygroscopic active shows as sticking, picking or capping on the press, it is worth trying before reworking the granulation, because it addresses the moisture rather than the binder system.
Can HR100 be used together with a moisture barrier coat?
Yes, and they solve different halves of the problem. HR100 handles moisture in the powder before and during compression. A barrier film such as MB 31RP or CVS-101 protects the finished tablet afterwards. A hygroscopic active that fights the press and then degrades on shelf needs both.
What does a hygroscopic active look like on the press?
Sticking, picking and capping are the usual signs, and they get worse as the shift goes on and ambient humidity rises. If the granulation was sound and the trouble started with the active, the moisture is the thing to address first.
RT-114 · Taste mask for Azithromycin and Ofloxacin
Which suspensions is RT-114 formulated for?
Azithromycin and Ofloxacin suspensions. It masks the taste and odour of the active through a solid dispersion approach rather than flavour loading on its own.
How is it checked?
A taste panel and assay, run together. A blend that tastes right but assays low has not solved the problem.
Can RT-114 be used for actives other than Azithromycin and Ofloxacin?
RT-114 is formulated for those two suspensions. Another bitter active needs a grade developed against it, the same way AC-8 is formulated against a specific core rather than taken off the standard list.
Is it applied through a coater?
No. It is blended into the suspension formulation, so there are no pan speeds or bed temperatures to set. The controls that matter are the taste panel and the assay.
MNaq series · Metallic and pearl film coat
Can a custom metallic shade be matched?
Yes. Send a reference sample and the shade is matched and confirmed against it before the batch is released, so a repeat order reproduces the finish you approved.
Does a shade change mean a process change?
No. Every code in the MNaq series runs on the same non-aqueous parameters, so switching shade does not mean requalifying the process.
Why does the finish look uneven on some cores?
A metallic effect depends on pigment lying flat, so the surface underneath matters as much as the coat. A smooth core, or a seal coat below the metallic layer, gives the pigment something even to lie on.
AQ-Z Wb · Aqueous film coat, white or colour
Is AQ-Z Wb supplied in colour or only white?
Both. It is a water base ready-mix film coat supplied white or in the shade agreed against your reference sample. The process is identical either way.
What limits the run on a small pan?
Spray rate. On a 12 inch conventional pan the charge is 0.5 to 1 kg and the pan turns at 18 to 20 rpm, so how fast you can spray without wetting the bed is the constraint. On a 36 or 48 inch auto coater the charge is large and pan speed drops, so inlet temperature and air volume carry the drying instead.
NaQ-Z1Wb · Non-aqueous film coat, white or colour
When should a solvent film coat be chosen over an aqueous one?
When the core cannot take water, not as a default. The aqueous grade is simpler to run and avoids solvent handling, so the solvent route is a decision driven by the core rather than by preference.
What temperature band does it run at?
The cooler of the two. Around 30 to 35 degrees at the bed against a 60 to 65 degree inlet, compared with 35 to 40 and 75 to 80 for the aqueous grades.
NaQ-Z1Wt10 · Non-aqueous film coat, extra white
How does NaQ-Z1Wt10 differ from NaQ-Z1Wb?
Opacity. Both run the non-aqueous band, but the Wt10 grade carries the covering power of the extra white series. It suits cores that are both moisture sensitive and hard to cover, where an aqueous extra white is not an option.
UZ1 · Universal film coat
Can one grade really run on both an aqueous and a solvent process?
Yes. UZ1 can be dispersed in water or in solvent, so the same code covers both product lines. Units that run mixed processes hold one grade in stores instead of two.
What has to be decided before dispersion?
Which route you are running, because the two use different temperature bands. Once the dispersion is made everything downstream is unchanged.
SFC101 · Sugar film coat material
Does SFC101 need a traditional sugar coating line?
No. It is applied like a non-aqueous film coat, so a single pan and a single dispersion replace the syrup, dusting and polishing stages. A conventional or auto coater is all that is required.
How long does a sugar coated finish take with it?
A single shift rather than the several days a traditional sugar process runs to, because the multi stage build-up is replaced by one film coating stage.
SC-501 · Colour or white seal coat
When is a coloured seal coat better than a transparent one?
On dark or mottled cores. SC-501 covers as well as seals, so the finishing film coat can then be applied at a lower build-up instead of carrying all the covering work itself.
AC-8 · Moisture barrier for special category tablets
What if our core is not covered by CVS-101, PA-Wt10 or MB 31RP?
That is what AC-8 is for. It is a solvent base moisture barrier formulated against the specific core, so parameters are agreed at the trial rather than read off the standard table. Send the core and the stability problem you are trying to solve.
SR100 · Sustained release material
What controls the release rate with SR100?
Weight gain. Release rate follows the amount applied, so the build-up is the control variable. It is fixed at trial against your target dissolution profile, then held batch to batch.
Why supply it as a ready-mix?
Because in-house polymer blending is where extended release profiles drift between batches. A ready-mix removes that variable, so the profile you qualified is the profile you keep.
RT314 · Dissolution enhancer blend
When is a dissolution enhancer the right fix?
When the core does not meet the specified disintegration time or dissolution profile and reformulating the core is not practical. It is added at the blending stage rather than applied as a coat.
How do we show the correction came from RT314?
Run disintegration and dissolution before and after addition on the same core. That separates the effect of the blend from ordinary batch to batch variation.
Does RT314 replace reformulating the core?
It is used where reformulating is not practical. If the core has a deeper problem than disintegration time, the blend corrects the symptom rather than the cause, and reformulation is still the better answer.
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