FAQ

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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 - 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

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 - 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 - 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.

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

What is the viscosity's of a non-crystalising liquid sorbitol such as NEOSORB 70/70 B?

Liquid sorbitol solutions are of low viscosity and are easy to manipulate and pump at normal room temperature:
10°C 450 mPa.s
20°C 200 mPa.s
30°C 100 mPa.s
40°C 50 mPa.s
Typically a liquid sorbitol such as NEOSORB 70/70 B has a viscosity versus temperature profile as shown in the figure bellow.
Pharma

What is the available information on the effect and dosage of polyols on newborn babies during the first months?

In Europe the pharmaceutical field does not impose any special restrictions on the inclusion of polyols in medicines for newborn babies, and this for the quite simple and valid reason that the medicine will be assessed on all its aspects via the AMM file.

The only known regulatory constraints are those of the European guidelines relating to excipients with well-known effects (EU guideline, July 2003).

When polyols are used in a medicine, the guidelines require certain information to be included in the instructions leaflet.

  EU guidelines on labelling of Medicinal products for human use, July 2003  Generally recognized caloric value for food applications

Mannitol
Over 10 g taken orally

May have a mild laxative effect

Calorific value depending on the regional area : 1.6 kcal/g in the US et 2.4 kcal/g in the EU

Maltitol
Taken orally

Patients with a rare heredity problem of fructose intolerance should not take this medicine

Calorific value depending on the regional area: 2kcal/g in Japan, 2.1kcal/g in the US et 2.4kcal/g in the EU and in the Mercosur.

Maltitol
Over 10 g taken orally

May have a mild laxative effect
Calorific value 2.3  kcal/g Maltitol
Calorific value depending on the regional area: 2kcal/g in Japan,  2.1kcal/g in the US et 2.4kcal/g in the EU and in the Mercosur.
Sorbitol
Oral or parenteral administration
Patients with a rare heredity problem of fructose intolerance should not take this medicine Calorific value depending on the regional area: 2.7 kcal/g in the US and 2.4 kcal/g in the EU
Sorbitol
Over 10 g taken orally
May have a mild laxative effect
Calorific value  2.6 kcal/g sorbitol
Calorific value depending on the regional area: 2.7 kcal/g in the US and 2.4 kcal/g in the EU
Xylitol
Over 10 g taken orally
May have a mild laxative effect Calorific value 2.4 kcal/g xylitol Calorific value 2.4 kcal/g

This dose is of course 10 g per day for an adult (Average body weight =70 kg) in good health. Special care has to be taken should polyols be administered to infants and children under 3.
There are already products on the market for small children and infants containing polyols, notably syrups and solutions.
Overall a prudent approach is appropriate but as indicated in one communication “Children more than younger or older adults are likely to consume larger amounts of freely available polyols; there is, however, no evidence that children are less able to tolerate polyols than are adults in terms of the weight of polyols per meal or day” (Spengler et al., 1987; Paige et al., 1992; A Lee, Salford University, personal communication)
In Europe in the food field our polyols (Mannitol, Maltitol, Sorbitol and Xylitol) are additives. They are therefore subject to the regulations laid down in Directive 95/2/EC and in its amended versions which concerns the conditions under which food additives can be used.

Annex IV of this directive applies more especially to the food additives for baby food (0 - 12 months) and food for young children (12 months - 36 months). In this annex it is stated that:
"preparations and cereal-based preparations and food for infants and young children may contain the substance E 421 (mannitol) when it is used as support for vitamin B12 (not less than 1 part of B12 for 1000 parts of mannitol)."

In other words, with the exception of mannitol as support for vitamin B12, it is not possible to use our polyols in baby food.


Again in the food field, the preparations for infants and follow-on preparations (children aged between 1 and 3 years) are more especially regulated by Directive 2006/141/CE.

Annex I of this directive gives the ESSENTIAL COMPOSITION OF INFANT FORMULAE.
In these preparations only a few carbohydrates can be used. These are:
Lactose / Maltose / Sucrose / Glucose / Maltodextrins / Glucose syrup or dried glucose syrup / Pre-cooked starch / Gelatinised starch.

Annex II of this directive gives the ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE.
In these preparations:
- Carbohydrates containing gluten are prohibited.
- Minimum or maximum contents are laid down for certain carbohydrates (lactose, sucrose, glucose)
- A minimum and maximum content of g/kcal is also laid down.
Except polyols, carbohydrates in compliance with the above conditions can be used in these Follow-on Formulae.

 

More information
Pharma

Does Roquette as a manufacturer has to perform identification tests?

No, following IPEC guideline on certificate of analysis.
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 - 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 - 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

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.

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