Poudre Lactose

29,99 $US
Plus que %1 en stock
SKU
5060477552285
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La Poudre de Lactose est produit familier des consommateurs. Elle a un large éventail d’utilisations. Elle améliorera la saveur, la texture et la couleur d’un comprimé et est généralement inerte.

La poudre de lactose de qualité pharmaceutique est souvent utilisée dans des comprimés et a des faibles niveaux d’impureté. C’est un glucide, ce qui signifie que c’est un disaccharide. C’est-à-dire qu’elle est dans la catégorie des sucres qui contiennent deux résidus de monosaccharide. Elle est composée d’environ 2-8% de lait comme déterminé par son poids. C’est un produit soluble avec un goût sucré peu prononcé. La poudre de lactose est transparente, incolore et inerte. Elle peut améliorer des éléments de sécurité d’un produit et rendre le processus de fabrication plus performant.

Qu’est ce que la Poudre de Lactose

Le Lactose est un glucide simple trouvé dans le lait. Une autre appellation est le sucre du lait. C’est un sucre réduit, ce qui veut dire qu’il réagit avec des acides aminés à de hautes températures. Cela peut déterminer la saveur finale. Lorsque la poudre de lactose est utilisée dans un comprimé, cela sera au travers de la méthode de compression directe. La qualité pharmaceutique est une poudre fine mais elle peut fonctionner en conjonction d’autres poudres de lactose. Des tailles de mailles plus petites rendent le mélange plus facile et plus efficace et les qualités plus grossières améliorent la fluidité. La poudre de lactose peut également être mélangée avec du saccharose pour créer des mixtures de revêtement sucrées.

La création de diverses qualités de poudre de lactose a fait beaucoup de progrès. Chaque classe produit une forme légèrement unique de poudre de lactose. Cela signifie que vous pouvez être plus spécifique avec les propriétés de votre formule. Chacune de ces différentes qualités ont des méthodes de fabrication différentes. Le lactose de qualité pharmaceutique est fabriqué avec une concentration de lactosérum pour saturer le lactose.

La perspective des consommateurs finaux doit être prise en considération durant la création du comprimé. La Poudre de Lactose est un ingrédient bien connu avec plusieurs utilisations et est familier pour le consommateur. Un problème auquel il faut faire attention est un consommateur qui souffre d'intolérance au lactose. Leur consommation de cet ingrédient peut avoir pour conséquent des crampes, diarrhées et flatulences.

La poudre de lactose de qualité pharmaceutique doit être stockées dans un endroit frais et sombre. Des températures inférieures à 27 degrés Celsius doivent être maintenues et une humidité inférieure à 65% car une humidité élevée peut entraîner la formation de moisissure.

La Poudre de Lactose est :-

  • Listée comme GRAS (généralement considéré comme sans danger)
  • Incluse dans la base de données des ingrédients inactifs de la FDA
  • Incluse dans des médicaments parentérales et non parentérales agréés au Royaume-Uni
  • Incluse dans la Liste Canadienne des Ingrédients non Médicinaux Acceptables

La Poudre de Lactose est un ingrédient largement accepté, qui est considéré sans danger partout dans le monde. Il améliorera la qualité et le goût de votre produit et vous obtiendrez un ingrédient qui convient parfaitement à diverses utilisations.

Nom Valeur
Numéro CAS 63-42-3
Formule moléculaire C12H22O11
Aspect Poudre blanche
Etat physique Solide
Stockage Stockez à température ambiante
Point d’ébullition 668.9 °C
Densité 1.525 g/cm3
Poids moléculaire 342.30 g/mol
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Are all excipients safe for all ages to consume?

Yes, it does not matter what age, size or sex the person consuming the products is. It is, however, important to check the intolerance data.

Are all the excipients safe for human consumption?

Yes, all of the excipients are safe for human or animal consumption. There are some precautions that should be taken when handling them and there are some people that might have intolerances to some of them. Information on this can be found in the products MSDS and Intolerance Data Sheet. This can be found in this section for every excipient.

Are there any known allergens or health risks?

Yes, there are all of them can be found in the intolerance sheets for each product. The intolerance sheets can be found here: https://www.lfatabletpresses.com/product-data

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Can I get a better price for excipients than is listed on the website?

Yes, we have bulk pricing for all of our excipients, and these can be found in this section. We offer bulk in 500 kg, 1 ton, 2 ton and 5 ton lots. The prices are set on these quantities as these are the amounts that will fit on pallets.

Can I have a CoA for my Excipient?

Yes. CoA stands for Certificate of Analysis this is also known some times as an MSDS (Material Safety Data Sheet) all of the information contained in a CoA is inside the MSDS for every LFA product which is emailed to you after purchase.

Dissolving rate? Any known factors that can affect the rate, speed up or slow down the breakdown of a tablet?

Yes. There are two things at play here. You can get hygroscopic and hydrophobic excipients. Hygroscopic means that they take on water quickly, while hydrophobic means that they repel water.

There are products know as supper disintegrants. These products help the breakdown of tablets. At the moment LFA does not sell any supper disintegrants.

Magnesium stearate is hydrophobic this means that it will slow the breakdown of a tablet.

However, it is used in such small amounts that most of the time it will not make a difference to our customer's products. If they would like to be sure then they should conduct what is known as a disintegration test.

How long is the storage period of each excipient? What is the shelf life?

Firmapress - 2 years form batch date.
Dextrose - 3 years from batch date.
Dicalcium Phosphate - 3 years from batch date.
Microcrystalline Cellulose -
Magnesium stearate -
Lactose - 2 years from batch date.
Silica Dioxide - 2 years from batch date.

How should I clean contact parts that have come into contact with my excipients or active ingredients?

here are 6 steps that should be followed as a general rule of thumb when cleaning contact surfaces that have come into contact with powders:

Dry Clean - First you need to remove as much of the dry powder as possible. You can do this using a hover/vacuum. Make sure that the vacuum you are using has a filter good enough to handle fine dust.

Wet Clean - Next you need to perform a wet clean. This can be done with warm water and soap or if available an ultrasonic cleaner.

Rinse - Next you need to rinse off any soap with potable water (drinking water). You do not have to do this if you used an ultrasonic cleaner in the last step. It is important to ensure that all parts are thoroughly dried immediately after washing to avoid any rusting.

Sanitise - Next you need to sanitise the surface. This step is recommended by the FDA. There are a number of sanitising solutions available designed to be applied and left on.

Lubricate - You now need to lubricate any parts that require it. This should be with the appropriate grade oil or grease considering your use and greasing chart. Store - Finally store any of the parts in a cool dry place. If you are storing them on the machine then make sure the machine is in a temperature controlled environment with low humidity.

What is the mesh size of your excipients? etc.

Dextrose - approx 100 mesh
Dicalcium Phosphate - approx 100 mesh
Microcrystoline Cellulose - approx 120-200
Magnesium sterate -
Lactose - 80 mesh
Silica Dioxide -
Firmapress - 100-200 mesh

What kind of agent is each excipient?/ What is the main use of each excipient?

Dextrose - Sweetener, binding agent, good for chewable tablets or candy.

Microcrystalline Cellulose - Binder, filling agent. Good at binding tablets and making them bigger. It can also be used as a filler for capsules.

Magnesium stearate - Dry Lubricant. This stops products from getting stuck to the tooling. It can also help with powder flow issues and caking issues.

Lactose - Binder, sweetener and bulking agent. It has a large mesh so it flows well but most people do not like it because of the intolerance issues.

Silica Dioxide - Flowing agent. This assist powders in flowing smoothly through the machines. It also helps with cacking issues where powders get stuck to the machine.

What kind of condition should excipients be stored in?

Firmapress - 2 years form batch date.
Dextrose - 3 years from batch date.
Dicalcium Phosphate - 3 years from batch date.
Microcrystalline Cellulose -
Magnesium stearate -
Lactose - 2 years from batch date.
Silica Dioxide - 2 years from batch date.

Which excipient should I add if the product doesn't bind well?

If your product does not bind well then we would recommend using MCC. This can be used in any % the limiting factor is the size of the tablet.

If the amount of MCC you would have to use would be too much or if you do not want to use MCC then you have 3 other options: Ask your supplier for a directly compressible or tabletable grade of your product. Spray dry your product. Wet granulate your product.

Which excipient should I add if the product is sticky?

If your product is sticky then you will need to add a dry lubricant to your mix. For this, we recommend magnesium stearate.

We do not recommend that you add more than 1% to the mix as more than this can cause capping. If your product is still sticky at this point then we would recommend looking into granulation.

Which excipient should I add if the product/API is clumpy?

If your product or API is clumpy then you will need to add an anticaking agent. For this, we recommend silicon dioxide. We only recommend adding a maximum of 2% of this to the mix

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