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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

Does Roquette as a manufacturer has to perform identification tests?

No, following IPEC guideline on certificate of analysis.
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

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.
Performance materials - About isosorbide

Is POLYSORB® isosorbide a bio-based monomer?

Yes. POLYSORB® isosorbide is obtained from sorbitol, a starch derivative. Starch produced by Roquette comes mainly from maize, wheat. Thus, POLYSORB® isosorbide can be considered as bio-based.
Performance materials - Safety

Are POLYSORB® isosorbide-based polymers considered as bio-based polymers?

POLYSORB® isosorbide is a bio-based monomer.

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.
Performance materials - About isosorbide

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,…

Performance materials - Polymer performance

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.

Performance materials - Polymer performance

What is the difference between standard polycarbonate and POLYSORB® isosorbide-based polycarbonate?

Standard polycarbonates are mainly composed of Bisphenol A, while by using POLYSORB® isosorbide, resin manufacturers can design special BPA-free polycarbonates.
Performance materials - Polymer performance

How can POLYSORB® isosorbide contribute to replace standard polycarbonate?

Using POLYSORB® as co-monomer in polyester resins like PET enables to create better performing materials.

With such improvement, they can pretend to be a BPA-free, safe plastic alternative to standard polycarbonate.
Performance materials - Polymer performance

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.

Performance materials - Polymer performance

What is POLYSORB® isosorbide impact on polymer glass transition temperature (Tg)?

Thanks to its original molecular design, POLYSORB® isosorbide often increase polymer Tg.

Performance materials - Safety

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.

Performance materials - Safety

How does Roquette provide Bisphenol A alternatives?

Roquette offers POLYSORB® isosorbide, a safe plant-based monomer that can be used to replace BPA, such as in polycarbonate.
Performance materials - Safety

How does Roquette provide Phthalates Alternatives?

Roquette offers POLYSORB® ID, a safe plant-based general purpose plasticizer that can be used to replace phthalate-based plasticizers, such as DINP.
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