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2010年03月30日

(2010-03-30 15:12:48)
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美国

杂谈

HYDROXYPROPYL METHYLCELLULOSE (U.S.A) 

Introduction

 介绍

       The European Pharmacopoeia describes hydroxypropyl methylcellulose (HPMC) as a partly ortho-methylated and ortho-(2-hydroxypropylated) cellulose. It is available in several grades that vary in viscosity and extent of substitution. Grades may be distinguished by appending a number indicative of the apparent viscosity (in mPa), of a 2% w/w aqueous solution at 20°C. As defined by the United States Pharmacopoeia (USP), HPMC specifies the substitution type by appending a four digit number to the nonproprietary name, HPMC 1828. The first two digits refer to the approximate percentage content of the hydroxypropoxy group, calculated on a dry basis. Molecular weight is approximately 10,000 to 1,500,000.

    欧洲药典描述羟甲基纤维素(HPMC) 如同ortho-methylatedortho (2 hydroxypropylated) 纤维素的一部分。根据黏度和代替程度的不同它可以被分成几个级别。在20°C 2%水溶液下,等级可以在给出的黏度后面附加指示性的数字来加以区分(in mPa 依照由美国药典定义(USP), HPMC 指定由添附四个阿拉伯数字来代替其名字, HPMC 1828 前两个阿拉伯数字表示大概的羟丙基含量, 是在干燥的基础上计算的。 分子量大约是10,000 1,500,000

HPMC is prepared when a purified form of cellulose is reacted with sodium hydroxide solution to produce a swollen alkali cellulose that is chemically more reactive than untreated cellulose. The alkali cellulose is then treated with chloromethane and propylene oxide to produce methylhydroxypropyl ethers of cellulose. The fibrous reaction product is then purified and ground to a fine, uniform powder or granules.

     当被净化的纤维素与氢氧化纳溶液反应产生一种膨胀碱性纤维素时,HPMC就产生了,这种纤维素在化学上比没有经过处理的纤维素更易起反应 碱性纤维素然后被氯代甲烷和丙烯氧化物处理生产出甲基羟丙基纤维素。 纤维状产品被净化和搁浅成一种精细的, 一致的粉末或颗粒

      HPMC is available commercially as an odorless, tasteless, white- or creamy white-colored, and fibrous or granular powder. Powdered or granular surface-treated grades of HPMC are also available that are dispersible in cold water. The dissolution rate of these materials can be controlled by a shift in pH, and they are therefore useful for slow release or enteric-coated formulas. HPMC is listed as generally regarded as safe and accepted as a food additive in Europe. It is also included in the Food and Drug Administration Inactive Ingredients Guide and meets USP and European Pharmacopoeia (EP) standards and Japanese pharmacopoeial standards.

     HPMC 可用于商业中作为无嗅, 无味, 白色或乳脂状白色, 含纤维状或颗粒状粉末。 表面处理的粉末或颗粒状的HPMC也很容易分散在冷水中。 这些材料的溶解率可能由PH值来控制, 并且他们因此可被用作缓慢释放或外涂层配方。 在欧洲,HPMC作为食品添加剂是安全和可被接受的。它并且包括在食品与惰性成分引导药物管理和符合USP 和欧洲药典(EP) 标准和日本药典标准。

 

Products

 

       HPMC has various applications in pharmaceutical formulations and is widely used in oral and topical formulations. In oral products, HPMC is primarily used as a tablet binder, in film coating, and as an extended-release tablet matrix. Concentrations between 2% and 5% w/w may be used as a binder in either wet or dry granulation processes. High-viscosity grades may be used to retard the release of water-soluble drugs from a matrix. Depending on the viscosity grade, concentrations between 2% and 10% w/w are used as film-forming solutions to film-coat tablets. Lower-viscosity grades are used in aqueous film coating solutions, while higher-viscosity grades are used with organic solvents.

HPMC在配药公式化方面有着各种应用并且被广泛的应用在口腔和局部的配方中。 在口头产品, HPMC 主要被使用作为片剂黏合剂, 在包衣涂层, 并且作为延长释放的药片包衣 集中在2% 5% 溶液之间可被用作黏合剂不管是在湿或干燥粒化过程中。 高黏性等级可被用于延迟溶解。 根据黏度等级, 集中在2% 10%之间的被使用作为涂层形成溶液用于药片的包衣涂层。 低黏度等级可被使用在film coating溶液, 然而高黏度等级被使用做有机溶液。

HPMC is also used as a suspending and thickening agent in topical formulations, particularly ophthalmic preparations. Compared to methylcellulose, HPMC produces solutions of greater clarity, with fewer undispersed fibers present, and is therefore preferred in formulations for ophthalmic use. Concentrations of between 0.45% and 1.0% w/w may be added as a thickening agent to vehicles for eye drops and artificial tear solutions.

    HPMC也可被使用作为涂层形成溶液用于药片的包衣涂层, 特别在眼药制备方面。 与甲基纤维素比较, HPMC 导致溶液更加的清晰, 只是回有较少未被分散的纤维, 因此更是眼科使用方面的首选。 0.45% 1.0% 的之间可做为增稠剂来配制眼药水和人造眼泪。

       HPMC is also used as an emulsifier, suspending agent, and stabilizing agent in topical gels and ointments. As a protective colloid, it can prevent droplets and particles from coalescing and agglomerating, thereby inhibiting formation of sediments. In addition, HPMC is used as an adhesive in plastic bandages and as a wetting agent for hard contact lenses. It is also widely used in cosmetics and food products.

    HPMC可在典型胶凝体和软膏里被用作乳化剂, 延缓剂,稳定剂。 作为防护胶体, 它可能防止小滴和微粒凝结成块, 从而抑制沉淀的形成。另外, HPMC 被使用为坚硬隐形眼镜作为胶粘剂在塑料绷带中和作为增湿剂。 它也被广泛应用在化妆用品和食品行业中。

       A wide range of viscosity types are commercially available. Aqueous solutions are most commonly prepared, although HPMC may also be dissolved in aqueous alcohols such as ethanol and propan-2-ol, provided the alcohol content is less than 50% w/w. Solutions prepared using organic solvents tend to be more viscous.

大范围黏度类型是商业应用。 水溶液是最容易准备的, 虽然HPMC 也能被水酒精里溶解譬如乙醇和propan-2-ol, 假设酒精含量少于50% w 解答配备倾向于是更黏的有机溶剂。

Grades and prices

    级别和价格

       There are two suppliers of HPMC to the U.S. ethical pharmaceutical marketplace: (1) The Dow Chemical Company and (2) Shin-Etsu Chemical Co. Ltd., represented by Biddle Sawyer in the United States. Selected HPMC products are listed below with corresponding supplier, trade name, and average market price per pound:

     在美国医药市场有两大HPMC供应商,道化学公司和由Biddle Sawyer代表的信越有限公司。以下是相应的HPMC供应商的产品商标和每磅的平均市场价:

Supplier

供应商

Trade name

商标

$/Lb

Dow Chemical

道化学

Methocel

 

5.85

Shin-Etsu

赫克利士

Metolose/Pharmacoat

5.85

 

 

       Shin-Etsu Chemical has two trade names for its HPMC. Their low-viscosity-type HPMC uses the PHARMACOAT trade name and is used as a film coating material and for binder applications. PHARMACOAT is available in various viscosity grades and meets USP and EP standards. The other trade name used for both HPMC and methyl cellulose is METOLOSE. This product is mainly used in sustained-release matrix applications, where hydrophilic matrix systems require water-soluble polymers.

    信越有二个HPMC商标。 他们的低黏度类型HPMC 使用PHARMACOAT 商标和被使用作为影片涂层材料和为黏合剂应用。 PHARMACOAT 可应用与各种的黏度级别并且符合USP EP 标准。 另一商标METOLOSE被用于HPMC MC 这个产品主要被使用在持续溶解应用, 它的亲水性系统要求水溶聚合物。

 

Use levels

 使用标准

       Depending on the end-use application, the use level of HPMC can vary, as shown below:

    根据最终应用, HPMC 的用途可能有变化,如下:

Application

应用

Typical use level, %

典型使用标准,%

Controlled-release tablet matrix

5.0–26.0

Film forming

2.0–10.0

Tablet binder

2.0–5.0

Suspensions悬浮

1.0–2.0

Ophthalmic preparations

0.5–1.0

Estimated consumption

 消费评价:

       U.S. consumption of HPMC for pharmaceutical applications is estimated at 6 million lb of dry (100% active) product. Approximately 80%, or 4.8 million lb, is used in ethical oral solid-dosage-form (OSDF) pharmaceuticals, valued at over $28 million in 2003. Of these 4.8 million lb, approximately 60% is estimated to be used in coatings applications and 40% is used for other excipient uses.

    美国对于HPMC在医药上的应用估计在6 百万磅。大约80%, 4.8 百万磅, 被使用在ethical oral solid-dosage-form (OSDF)  配药, 2003 年总价值超过$28 百万。 4.8 百万磅, 大约60% 估计被使用在涂料 40% 被使用于其它赋形剂使用。

Customer base

 消费基础

In the pharmaceutical market, a few large pharmaceutical customers account for the majority of HPMC sales for Dow Chemical and Shin-Etsu. Most large pharmaceutical companies purchase HPMC, including Abbott Laboratories, Bristol-Myers Squibb, Johnson & Johnson, Merck & Co., and Pfizer, among others.

在配药市场上, 几家大的医药客户占了道化学和信越HPMC 销售的大半。 多数大制药公司购买HPMC, 包括Abbott Laboratories, Bristol-Myers Squibb, Johnson & Johnson, Merck & Co., and Pfizer之一。

Suppliers

 供应商

Dow Chemical is the leading U.S. HPMC supplier for ethical pharmaceutical applications, with sales estimated at almost 3.4 million lb, valued at $19.6 million in 2003, representing a 70% share of the market by both volume and value. Shin-Etsu Chemical is the next leading supplier, with HPMC sales estimated at 1.4 million lb, valued at $8.4 million in 2003, as shown below:

       道化学制品是美国HPMC用于医药应用方面的重要供应商, 销售量估计在3.4 百万磅, 2003 年销售额超过$19.6 百万, 代表市场70% 的份额和价值。 信越化学制品是另一个占主导地位的供应商, HPMC 销售估计在1.4 百万磅, 2003 年销售额超过$8.4 百万, 依照被显示如下:

 

Thousand千

 

% Of total

Supplier供应商

Lb磅

$

 

Volume

份额

Value

估价

Dow Chemical道化学

3,360

19,656

 

70

70

Shin-Etsu Chemical

信越

1,440

8,424

 

30

30

Total总计

4,800

28,080

 

100

100

 

 

       Selected HPMC products sold in the U.S. ethical OSDF pharmaceutical market are provided below with supplier, trade name, and equivalent product types:

    下边是在美国医药市场其它HPMC供应商的商标和与道化学,信越等同物产品的型号的对比

 

Trade name

Product产品

Dow

Shin-Etsu

Methyl cellulose

Methocel A

Metolose SM

Hypromellose 2910

Methocel E

Pharmacoat

Hypromellose 2910

Methocel E

Metolose 60SH

Hypromellose 2906

Methocel F

Metolose 65SH

Hypromellose 2208

Methocel K

Metolose 90SH

New Source

 新的来源

       Aqualon is reportedly adding HPMC to its line of USP- and EP-approved products. According to company sources, this was due to customers requesting that Aqualon begin supplying product, as they were concerned with existing supply and quality. Aqualon has been producing HPMC in Doel, Belgium, for the nutritional, food, and personal care markets for many years. Reportedly, the company will be introducing its pharmaceutical grades in early 2004 under the existing BENECEL trade name.

    赫克利士 据报道增加HPMC USP- EP 批准的产品它的线 根据公司来源和顾客请求, 赫克利士开始供应产品, 因为他们关心现有的供应品和质量。赫克利士生产的HPMC Doel和比利时营养, 食品,个人护理市场上已有许多年。 据报道, 公司将在2004年早期推出以BENECEL为商标的医药级产品。

 

Channels of distribution

 销售渠道

       Dow Chemical uses both a direct sales force and distributors to sell to pharmaceutical companies in the U.S. market. Shin-Etsu material is distributed exclusively in the United States by Biddle Sawyer, based in New York, NY.

    在美国市场,道化学制品使用直接销售和经销商来出售给制药公司。 信越由Biddle Sawyer作为总的经销商,总部在纽约。

 

outlook

 展望

       U.S. consumption of HPMC in pharmaceutical applications is forecast to grow at an average rate of 4% over the next five years, reaching over 5.8 million lb, valued at $34 million in 2008. This growth largely reflects sustained use of HPMC in film-forming applications and controlled-release applications.

    美国对HPMC在医药应用方面消费在未来5年估计将按4%增长,超过5.8 百万磅, 2008 年将超过$34 百万。 这种大的增长同样存在于HPMCfilm-forming 应用和控制释放应用中。

 

Appraisal

 评价

       Dow currently has the dominant market position in the U.S. ethical HPMC market; however, it has also reportedly had quality problems in the past few years. This stems from the attempted transfer of production from Dow’s Midland, MI, site to its Plaquemine, LA, site in 2001. These problems have since been rectified, and product quality is back to normal. In the interim, some customers were forced to find another source of product. Dow’s sales will grow at modest rates, close to industry growth rates in the United States, and the company is expected to retain its dominant market posture.

    道化学当前在美国HPMC市场占有统治地位; 然尔, 它也被报道在过去几年存在质量问题。 这是由于他们再2001试图从它的Midland, MI,转移到Plaquemine, LA 这些问题现已被矫正了, 并且产品质量回到了正轨。 在此期间, 一些顾客被迫去寻找其它货源。 道化学的销售将以适当的比率增长, 紧挨在美国的产业增长比率, 并且公司被认为将仍然保持它的市场统治地位。

       Shin-Etsu Chemical has a long history of supplying cellulosic-based excipients to the U.S. pharmaceutical market and is committed to supplying the market long-term. They are viewed in the industry as supplying very high-quality products at competitive prices and being responsive to customers’ product needs.

信越化学供应美国医药市场已经有很长的历史,并且是长期的。 他们被认为能在工业中提供有竞争性价格的高品质产品并且能响应顾客的需要。

       Aqualon is expected to introduce its BENECEL HPMC in January of 2004 to the U.S. market. Market penetration will be a long-term commitment, as product life cycles are long and requalification is expensive.

    赫克利士 被预计将于2004年一月将它的BENECEL HPMC打入美国市场。 市场渗透将是一个长期的工作, 因为产品寿命周期是长的,受限制和昂贵的。

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产地:山东淄博
联系人:杨光         
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