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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

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.
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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.

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.

 

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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.
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