FAQ

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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

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

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 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

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

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 - 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.
 

Pharma - Quality status

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

GMP, or Good Manufacturing Practices, are a set of official production standards and as such only make sense when the appropriate reference is indicated. Probably the most widely recognised GMP standards for active ingredients are the ones defined by the US FDA under  legislation  21 CFR, part 210-211. For instance, ROQUETTE’s LYCADEX PF has been assessed on a repeated occasions and has met these standards. However, there are other institutions that have set different GMP guidelines, such as WHO and IPEC.  The question of GMP certification has to be considered in the context of the specific product and local regulatory requirements.

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

Pharma - Quality status

Do Roquette APIs conform to ICHQ7A?

The implementation of the new European Pharmaceutical Directive (2004/27) have come into force on October 30, 2005. After that, each Active Pharmaceutical Ingredient will have to follow Good Manufacturing Practices according to the International ICHQ7A reference system. Roquette is therefore preparing to apply this quality reference system to its active ingredients.

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

Pharma - Stability or tox studies

Are stability studies available for Roquette's APIs?

Most of Roquette's products – and their stability – have been established over many decades and are well known. That stability has been once again confirmed by recent studies.

For more information on the toxicological status of a particular product please contact us or your local representative.

Pharma - Stability or tox studies

Are there toxicological studies available for Roquette products?

Roquette has long experience in the manufacture of active and inactive pharmaceutical ingredients. Most of these products are commonly sold as additives or ingredients to the food industry. They do not therefore require specific toxicological studies. The other non-“food grade” types are covered by toxicological studies. 

For more information on the toxicological status of a particular product please contact us or your local representative.

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