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.
Does Roquette as a manufacturer has to perform identification tests?
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.
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.
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.
Is POLYSORB® isosorbide a bio-based monomer?
Are POLYSORB® isosorbide-based polymers considered as bio-based polymers?
However, polymers based on isosorbide are produced with other co-monomers.
It is recommended to contact the resin manufacturer to have more information of final bio-based content of the material.
What is POLYSORB® isosorbide?
POLYSORB® isosorbide is a cycloaliphatic monomer obtained from sorbitol dehydratation.
Sorbitol is a polyol obtained from glucose, the starch monomer.
Starch is the main component of plant-based raw materials such as maize, wheat,…
Are POLYSORB® isosorbide-based polymers UV resistant?
Thanks to its non-aromatic (cycloaliphatic) structure, POLYSORB® isosorbide does not introduce into polymers UV sensitive bonds, enabling higher UV resistance to plastics.
What is the difference between standard polycarbonate and POLYSORB® isosorbide-based polycarbonate?
How can POLYSORB® isosorbide contribute to replace standard polycarbonate?
With such improvement, they can pretend to be a BPA-free, safe plastic alternative to standard polycarbonate.
What can be done to increase the glass transition temperature (Tg) of polyethylene terephthalate (PET)?
Polyethylene terephthalate (PET) glass transition temperature limits its use, notably in packagings subject to heating.
By introducing POLYSORB® isosorbide as co-monomer during the resin synthesis, PEIT (polyethylene-co-isosorbide terephthalate) resin is created. POLYSORB® isosorbide introduction boosts resin temperature resisitance, enabling the use of PEIT in new demanding packaging applications.
What is POLYSORB® isosorbide impact on polymer glass transition temperature (Tg)?
Thanks to its original molecular design, POLYSORB® isosorbide often increase polymer Tg.
Are all POLYSORB® isosorbide-based plastics approuved for food contact?
Food contact regulation depends both on country regulation and plastic type.
It is recommended to contact the resin manufacturer to have more information on it.