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Lactosa en Polvo

29,99 $
SKU
5060477552285
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La lactosa en polvo es un producto familiar para los consumidores, con una gran variedad de usos. Mejora el sabor, textura y color de su tableta, y normalmente no es reactivo.

La lactosa en polvo de grado farmacéutico es ampliamente utilizada en tabletas y tiene un bajo nivel de impurezas. Es un carbohidrato, lo cual significa que es un disacárido. Esta clase de azúcares contiene dos residuos de monosacáridos. Según lo determinado por el peso, es un ingrediente de la leche en un 2% a un 8%. Es un producto soluble, con bajo nivel de dulzor. La lactosa en polvo es transparente, incolora e inerte. Puede mejorar la seguridad del producto, y facilita el proceso de elaboración.

Qué es la lactosa en polvo

La lactosa es un carbohidrato sencillo que se encuentra en la leche. También se conoce como azúcar de la leche. Es un azúcar reductor, por lo que reacciona con aminoácidos a altas temperaturas. Esto puede determinar el sabor final. El uso de lactosa en polvo en las tabletas puede darse en el método directo de compresión. La lactosa y anhidros secos son capaces de formar una tableta sólida bajo compresión. En su grado farmacéutico es un fino polvo, pero puede utilizarse conjuntamente con otras lactosas en polvo. Las mallas de menor tamaño hacen que el proceso de mezclado sea más fácil y eficiente, y las más grandes mejoran el flujo. La lactosa en polvo puede mezclarse también con sacarosa para crear mezclas de revestimiento de azúcar.

La creación de los diferentes grados de lactosa en polvo ha pasado por muchos avances. Cada grado produce una forma ligeramente diferente de lactosa en polvo. Gracias a ello, puede ser más específico con las propiedades de so fórmula. Cada uno de estos grados tiene distintos métodos de fabricación. La lactosa de grado farmacéutico se elabora con una concentración de suero de leche que satura la lactosa.

Desde el punto de vista del usuario final, deben tomarse ciertas consideraciones al crear tabletas. La lactosa en polvo es un ingrediente muy conocido y familiar para el consumidor. Debe tener en cuenta que ciertos consumidores pueden ser intolerantes a la lactosa. El consumo de este ingrediente podría ocasionar en ellos calambres, diarrea y flatulencia.

La lactosa en polvo de grado farmacéutico debe almacenarse en un lugar fresco y oscuro. La temperatura de almacenamiento debe ser inferior a 27 grados Celsius, con una humedad por debajo del 65%. Una mayor humedad podría desencadenar moho.

La lactosa en polvo es:

  • Listada como "GRAS" (Generalmente Reconocida como Segura)
  • Está incluida en la base de datos de la FDA de ingredientes inactivos
  • Está incluida en medicamentos parenterales y no parenterales con licencia en Reino Unido
  • Está incluida en la Lista Canadiense de Ingredientes No-Medicinales Aceptados
  • La lactosa en polvo es un ingrediente muy aceptado que se considera seguro en todo el mundo. Mejorará la calidad y el sabor de su producto, y descubrirá que encaja perfectamente en una gran variedad de aplicaciones.

    Nombre Valor
    Número CAS 63-42-3
    Fórmula molecular C12H22O11
    Apariencia Polvo blanco
    Estado físico Sólido
    Almacenamiento Almacenar a temperatura ambiente
    Punto de ebullición 668,9 °C
    Densidad 1,525 g/cm3
    Peso molecular 342,30 g/mol
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    Can I get a better price than is listed on the website?

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

    Firmapress
    Weight Price £ Price $ Price €
    500kg 5,808.23 7,500.00 6,632.40
    1 Ton 10,842.02 14,000.00 12,380.48
    2 Ton 20,135.18 26,000.00 22,992.32
    5 Ton 46,465.80 60,000.00 53,059.20

    Microcrystalline Cellulose
    Weight Price £ Price $ Price €
    500kg 2,230.36 2,880.00 2,546.84
    1 Ton 3,568.57 4,608.00 4,074.95
    2 Ton 6,245.00 8,064.00 7,131.16
    5 Ton 14,497.33 18,720.00 16,554.47

    Dicalcium Phosphate
    Weight Price £ Price $ Price €
    500kg 1,626.30 2,100.00 1,857.07
    1 Ton 2,602.08 3,360.00 2,971.32
    2 Ton 4,553.65 5,880.00 5,199.80
    5 Ton 10,570.97 13,650.00 12,070.97

    Magnesium Stearate
    Weight Price £ Price $ Price €
    500kg 1,053.22 1,360.00 1,202.68
    1 Ton 1,685.16 2,176.00 1,924.28
    2 Ton 2,949.03 3,808.00 3,367.49
    5 Ton 6,845.96 8,840.00 7,817.39

    Silicon Dioxide
    Weight Price £ Price $ Price €
    500kg 3,670.80 4,740.00 4,191.68
    1 Ton 5,873.28 7,584.00 6,706.68
    2 Ton 10,278.23 13,272.00 11,736.70
    5 Ton 23,860.19 30,810.00 27,245.90

    Lactose Powder
    Weight Price £ Price $ Price €
    500kg 3,330.05 4,300.00 3,802.58
    1 Ton 5,328.08 6,880.00 6,084.12
    2 Ton 9,324.14 12,040.00 10,647.21
    5 Ton 21,645.32 27,950.00 24,716.74

    Dextrose Monohydrate
    Weight Price £ Price $ Price €
    500kg 1,115.18 1,440.00 1,273.42
    1 Ton 1,784.29 2,304.00 2,037.47
    2 Ton 3,122.50 4,032.00 3,565.58
    5 Ton 7,248.66 9,360.00 8,277.24

    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.

    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.

    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.

    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

    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 all excipients safe for all ages to consume?

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

    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.

    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.

    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

    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 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.

    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.

    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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