乳糖粉

from as low as US$ 15.80/kg
SKU
5060477552285
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乳糖粉是消费者比较熟悉的一种产品。其应用十分广泛。它能提升片剂的味道、口感和颜色,而且不会与其他物质发生反应。

医药级乳糖粉通常用于压片过程中,而且纯度很高。它是碳水化合物,也就是说,它是一种双糖,属于糖类,含有两个单糖分子。乳糖占牛奶重量的2-8%。它易溶于水,甜度低。乳糖粉无色透明,是一种惰性物质。它能提升产品的安全性,让生产过程更加顺利。

什么是如糖粉?

乳糖是牛奶中的一种简单碳水化合物。它是一种还原糖,能在高温条件下和氨基酸发生反应。这将决定最终的风味。当乳糖粉应用于片剂中时,是通过直接压缩的方法。喷雾干燥法和脱水法得到的乳糖均能通过压缩制成固体片剂。这种医药级的细粉末可以与其他乳糖共用。精细的乳糖更容易与其他物质混合,而较粗的乳糖提高粉料的流动性。乳糖粉可以与蔗糖混合,制成糖衣料。

不同级别的乳糖有所不同。每一级别都有独特的性质。这也意味着使用不同级别的乳糖粉能让您的配方与众不同。这些不同的乳糖有不同的加工方法。医药级乳糖通过浓缩乳清,直至乳糖饱和析出。

在制作片剂的过程中,最终用户的看法也应考虑。乳糖粉是一种广为人知的成分,使用广泛。需要注意的一点是,有些消费者有乳糖不耐症。如果他们服用含乳糖的片剂,可能会腹部狡痛、腹泻和胀气。

医药级乳糖粉需要在低温无光的环境下保存。稳定应低于27摄氏度,湿度应低于65%,高湿度导致乳糖发霉。

乳糖粉是

  • “一般认为安全”的成分
  • 属于FDA不活跃成分的范畴
  • 属于英国非注射和注射医药的范畴
  • 属于加拿大可接受非医药成分的范畴
  • 乳糖粉被广泛接受,在全球都被认为是安全的成分。它能改善您的产品的质量和味道,而且是能广泛应用于多种配方的成分。

    项目 数值
    CAS登录号 63-42-3
    分子式 C12H22O11
    外观 白色粉末
    物理形态 固体
    储存条件 室温储存
    沸点 668.9℃
    密度 1.525 g/cm3
    分子量 342.30 g/mol
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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.

    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 consuming the products is. 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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