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.
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.
Are stability studies available for Roquette's APIs?
What is the viscosity's of a non-crystalising liquid sorbitol such as NEOSORB 70/70 B?
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.
What is the available information on the effect and dosage of polyols on newborn babies during the first months?
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|
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
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.
|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.|
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|
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|
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.
Does Roquette as a manufacturer has to perform identification tests?
Can a generic manufacturer use a different ingredient/excipient while still submitting drug as a generic?
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.
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.
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.
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.
Does Roquette supply pyrogen-free products?
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
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.
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.
How does sorbitol ingestion influence blood glycemia?
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.