FAQ

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Pharma

Can a generic manufacturer use a different ingredient/excipient while still submitting drug as a generic?

The generic needs to have the same API (Active Pharmaceutical Ingredient) composition (qualitative and quantitative) as the one of the brand leader.
There is no obligation to have the same composition in excipients, even though some generic companies prefer to stick to the same excipients as long as they have the same dosage form.
ex.: immediate release film-coated tablet,  there is no problem to use Lycoat or ReadiLycoat instead of HPMC or PVA  based coating system as long as it has the same functionality.
Pharma

Does Roquette as a manufacturer has to perform identification tests?

No, following IPEC guideline on certificate of analysis.
Pharma - Formulation related

Can LYCASIN® be used for diabetic formulations?

LYCASIN® has been classified in Europe as having a reduced caloric level of 2.4 Kcal/day.  For diabetic patients this is therefore a useful ingredient but one that has to be taken in amounts that observe the recommended glucidic intake. 

For more information on LYCASIN®, please use our Products & Applications selection page

Pharma - Formulation related

What is the typical level of lubrication required for tableting with mannitol PEARLITOL® SD?

The level of lubrication required depends on many variables, notably the physical nature of the powder mixes. For PEARLITOL® Mannitol the recommended level of lubricant can be up to 1.5 - 2.0% of magnesium stearate, in particular for unusual tablet shapes.

For more information on PEARLITOL®, please use our Products & Applications selection page.

Pharma - Formulation related

What products does Roquette offer for liquid oral formulation (both those using sugar and those that are sugar-free)?

Roquette offers a variety of products, with both traditional sugar and sugar-free status, for the formulation of liquid formulations. For more information on the available products, please use our Products & Applications selection page.

For more information on this issue, please contact us or your local representative.

Pharma - Formulation related

Does Roquette supply pyrogen-free products?

Roquette offers a comprehensive range of PF products for the preparation of injectable and dialysis solutions.

For more information on the individual products, please use our Products & Applications selection page.

For more information on this issue, please contact us or your local representative.

Pharma - Formulation related

I am working on formulating chewable tablets; which Roquette excipients are best for this application?

Roquette offers a variety of great tasting products with the right technological properties for the formulation of chewable tablets. For more information on the available products, please use our Products & Applications selection page.

For more information on this issue, please contact us or your local representative.

Pharma - Formulation related

We are trying to develop Oral Disintegrating Tablets: what expertise and excipients does Roquette offer?

Roquette has long experience in the development of excipients suitable for ODT, of which some are the best suited to meet these technologically challenging formulations. 

For more information on the available products, please use our Products & Applications selection page.

If you have a particular formulation in mind, and would like our assistance, or need more information on ODT, please contact us or your local representative.

Pharma - Formulation related

Why is LYCASIN® recommended for paediatric formulations?

LYCASIN® has a taste and texture very similar to that of saccharose.  It can replace saccharose in medicinal syrups to create sugar-free formulations.
The tooth-friendly characteristics of LYCASIN® are proven, making use of this product particularly indicated for paediatric syrup formulations, of which night-time administration after teeth brushing is a common occurrence.

For more information on LYCASIN®, please use our Products & Applications selection page.

Pharma - General regulatory

Do Roquette’s liquid sorbitols comply with the USP/NF monograph?

Liquid sorbitol solutions contain not only sorbitol (D-glucitol) but other related hydrogenated oligomers and polymers of dextrose. All Roquette liquid sorbitols for pharmaceutical applications conform to either the USP or the NF monograph.
For historical reasons the USP monograph defines D-glucitol-rich solutions, commonly known as Crystallising Liquid Sorbitol, as containing a minimum of 64% of D-sorbitol w/w, whereas the NF monograph defines a lower-content D-glucitol syrup, known as Non-Crystallising Liquid Sorbitol, with a minimum content of 54% of D-sorbitol.

For more information on NEOSORB® Liquid sorbitol, please use our Products & Applications selection page.

Pharma - General regulatory

Do Roquette products comply with Pharmacopeias?

Roquette products conform with the current monographs of the three reference Pharmacopoeias (USP, EP, JP/JPE). If no monograph is available, Roquette can establish the appropriate specifications.

For more information on this issue, please contact us or your local representative.
 

Pharma - General regulatory

Is DMF documentation available for Roquette products?

Roquette has issued several DMFs for excipients or active ingredients;
Access to these DMFs can be given upon request.
Not all excipients or actives need a DMF so Roquette has developed alternative procedures that provide access to the information required by the regulatory authorities.

For more information on this issue, please contact us or your local representative.
 

Pharma - General regulatory

What documentation is available for the CTD (Common Technical Document)?

Roquette can provide all the information requested  in the standard Common Technical Document (CTD). However, in order to simplify the customer’s NDA files, Roquette has not only submitted several DMFs to the US authorities but also several CEPs (Certificate of Suitability to the monograph) to the European Medicinal Authorities (EDQM). Roquette DMF and/or CEP Access Letters are therefore available to the NDA applicant upon request.
Moreover, in connection with the New Pharmaceutical Affairs Law (New PAL), implementation, Roquette is preparing new DMF submissions to the Japanese authorities.

For more information on this issue, please contact us or your local representative.
 

Pharma - Packaging - Storage conditions

What are the required storage conditions for Roquette products?

Most of Roquette’s products are well known and their stability when stored in the original sealed packaging established over many decades. The standard storage conditions apply to these products, i e normal temperatures and cool, dry conditions. 
For certain products there might be a need for special temperature or care measures to counter humid conditions. For full details please consult the relevant product specification sheet.

For more information on this issue, please contact us or your local representative.
 

Pharma

How does sorbitol ingestion influence blood glycemia?

Sorbitol is a natural sweetener that can be found in some fruits (apple, pear, plums, cherry, peach) or in the sorbs berry. It is sugar-alcohol or a polyol, industrially prepared from glucose hydrogenation; it can substitute  sugar and very slightly increases  blood glycaemia and insulinemia after ingestion.
The glycemic response after 50 g sorbitol ingestion is evaluated to be approximately 10% of the response to the same amount of glucose.
One of the reasons for this, is that sorbitol is not glucose alone  and is only 30% absorbed in the small intestine, where it goes through the intestinal mucosa into the blood. The remainder  is further fermented in the colon. Through internal metabolism, sorbitol can be partly converted to glucose, which would explain the results of the glycemic measurements after ingestion: a very low increase.
In terms of limits in the use of Sorbitol in specific diabetic diets, only a physician with access to a patient’s full medical history can advise on this. Please take advice from your physician.
More information
Pharma - Quality status

Are Roquette products GMO-free?

Roquette manufacturing in Europe is exclusively GMO-free, backed up by third-party certification of maize or corn supply.

For more information on this issue, please contact us or your local representative.
 

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