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什么样的赋形剂才完美？能让顾客消化更容易，能让生产商压片更简单，不仅是合法合规的添加剂，还能超出一般功能。微晶纤维素就是这样一种完美的粘合剂。同其他粘合剂相比，它不像甲基纤维素那样容易胶化，而是保持一定的脆度，同时保持适量的润滑感。
微晶纤维素的主要功能
- 高兼容性
- 提升流动性
- 强力粘合剂
- 无嗅、无味
- 不与其他物质发生反应
- 低吸收能力
微晶纤维素，简称MCC，是在限制条件下生产出来的一种产品。最终成品应该是纯净、无嗅、无味的白色的粉末。加入粉料中，使压出来的片剂更加坚固有型。MCC保持稀释剂的必要优势。它是构成片剂或胶囊的膨胀剂，让压出来的片剂或胶囊具有适当的重量。微晶纤维素体积密度小，提高粉料的流动性。流动性高能保证粉料的每种成分充分混合，均匀分布。粉料均匀才能确保压出来的片剂品质如一。
为什么选择微晶纤维素？
微晶纤维素适合作为粘合剂，而且发挥重要作用。它能兼容其他流行的赋形剂，是许多生产商的配方必不可少的一种原料。粘合剂毫无疑问是压片过程中的至关重要的部分，因为他们能决定片剂的“硬度”。另外，粉料的压缩性直接影响压片成品的各个方面，比如崩解度、溶解度和吸收度等。MCC微晶纤维素可以直接压缩，不需要制粒或混合，可以直接拌入粉料中压片，让整体生产流程更加高效。
压缩性和粘合性都是微晶纤维素的重要特征，这一点毫无争议。这些特征防止它以片剂形式存在时不会轻易溶解，这对于胶囊和片剂而言，都是非常重要的因素。微晶纤维素正常用量对人体安全无害，作为压片赋形剂广泛应用。它也是一种天然的膳食纤维，无热量。最关键的一点是，微晶纤维素是一种惰性物质，不会与其他物质发生反应。
LFA的观点
综上所述，微晶纤维素可能是您想寻找的完美的赋形剂。它具有出色的粘合能力，是最受欢迎的膨松剂之一。有了这种原料，您制定压片粉料配方将变得更加容易。微晶纤维素所具有的优势及用途，将决定其成为完美的粘合剂选择。使用微晶纤维素和其他赋形剂将能是压片过程更加顺畅、更加高效。
| 项目 | 树值 |
|---|---|
| CAS登录号 | 9004-34-6 |
| 分子式 | (C6H10O5)n |
| 外观 | 白色细粉末 |
| 物理形态 | 固体 |
| 储存条件 | 室温储存 |
| 熔点 | 260–270°C；500–518°F |
| 密度 | 1.5 g/cm3 |
| 是否溶于水 | 否 |
| 文件 | 不耐受数据 技术参数 |
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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
FFFFFF Are your Excipients natural?
Yes, all of our Excipients are extracted from natural sources. For more information please visit the individual product pages.
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.
Can I produce tablets without Excipients?
It is unlikely that you will be able to produce tablets without using any Excipients at all. Certain products do bind without Excipients, but then do not flow through the machine. We advise that you use our Firmapress ready mix as this works with 99% of products.
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 difference between the range of excipients?
We offer Microcrystalline Cellulose, Magnesium Stearate, Dicalcium Phosphate and Firmapress in our range of excipients.
Microcrystalline Cellulose is a binding agent, which holds the content of the tablet together.
Dicalcium Phosphate is a flowing agent and helps move ingredients through the machine before they are compressed.
Magnesium Stearate is a dry lubricant and helps again with the movement of ingredients through the machine but also helps with the ejection of the tablets from the machine. Please note that Magnesium Sterate does not bind by itself.
Firmapress is an all in one mix of Microcrystalline Cellulose, Magnesium Stearate and Dicalcium Phosphate.
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