Microcrystalline Cellulose Powder.pdf

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1、 NANDINI CONSULTANCY CENTER March 2009 MICROCRYTALLINE CELLULOSE POWDER ; GLOBAL AND INDIAN SCENARIO INSIGHT AND ANALYSIS FOR THE CHEMICAL INDUSTRY Microcystalline Cellose Powder Global and Indian Scenario Page 2 Micro crystalline cellulose powder (MCCP) , a naturally occurring polymer, is derived

2、 from high quality wood pulp. MCCP is white, odourless, tasteless and free from organic and inorganic contamination, insoluble in water, dilute acids and most solvents. It is stable, safe and physiologically inert. Application sector * Pharmaceutical * Food Application in Pharmaceutical sector For d

3、irect compression tableting Unique morphology of MCCP provides strength to the tablets, low lubricant sensitivity and fast disintegration power.MCCP makes tablets strong by virtue of large number of binding sites and high surface area. It makes tablets porous and water permeates deep into tablet mat

4、rix quickly and fast disintegration of tablet is achieved For wet granulation Due to its wicking action, MCCP thoroughly distributes granulating fluid throughout the powder. With high surface area, it ensures rapid and uniform drying of wet granulation. MCCP prevents over wetting and maintains wet m

5、ass consistency due to its large surface area and absorptive capacity and it helps trouble free screening due to uniform wetting of powder. It distributes drug evenly throughout the particles of granulation and prevents drug or dye migration during drying.It possesses wet binding power and reduces t

6、he requirement of traditional wet binders. Microcystalline Cellose Powder Global and Indian Scenario Page 3 Application in Food industry MCCP is used in the following food products * Low calorie food like cookies; makroni and spaghetti * Butter, Cheese, Margarine, Free flowing granular powders of S

7、yrups, Honey, * Salad dressing and chocolate drinks. MCC of food grade, generally has a purity 99%. It also satisfies the microbiological requirements of a food additive. On blending with a soluble polysaccharide,e.g. CMC or guar gum, it can be dispersed into water as a stable gel. MCC co-processed

8、with soluble polysaccharides and in a dispersible gel form are commercially marketed as food additives. Physical properties of colloidal dispersions of MCC are different from those of gum solutions and gels produced by gelling hydrocolloids. MCC retains the usual chemical properties of cellulose; e.

9、g. the hydroxyl groups in its molecules can be esterified or etherified. Non food applications There are technical i.e. non-food applications of MCC. These include chromatographic media in t.l.c. analysis,where the resolution is improved by using MCC coated plates, compared to natural cellulose powd

10、er coated t.l.c. plates. Wax polishes and paints containing MCC give improved performance. Addition of MCC improves physico mechanical performance of composites, including those of thermoplastics polymers and particle board Substitution products in tablet formulations Filler used with the classical

11、wet granulation in tablet formulations include the following * Lactose * Starch * Calcium phosphates * Microcrystalline cellulose Microcystalline Cellose Powder Global and Indian Scenario Page 4 The tablet formulators may be using starch, dicalcium phosphate, microcrystalline cellulose powder or la

12、ctose or combination of them as fillers. The choice of fillers is guided by the nature of the dry formulation and the practice is increasingly emerging to use combination of fillers and excipients to get the optimum properties and results. A few formulators in the country use starch as substitute fo

13、r MCCP. This is so, since the price of starch is low as compared to MCCP. However, there are a number of disadvantages in using starch, since it causes fermentation while in use. Further, the shelf life of starch is low. MANUFACTURING PROCESS Micro crystalline cellulose powder is produced by the rea

14、ction of wood pulp with dilute mineral acid. Generally hydrochloric acid is employed, but less frequently sulphuric acid is also used. MCCP can also be produced from other sources such as groundnut shell, which is an agro waste. For production of MCCP, cooking of naturally occurring cellulose is don

15、e with dilute mineral acid to partially hydrolyse purified wood pulp or cotton. Hydrolysis at 100 to 130 deg.C completes in 0.5 to 1.0 hour. This will destroy the amorphous region of the fibrous material, leaving fine crystals of cellulose parcels. When the hydrolysis would be complete the wet cake

16、is filtered, neutralised and washed. During drying, MCC crystals agglomerate, which affects its properties. Hence, after drying the cake, it is mechanically fragmented in a ball mill for 3 to 4 hours to break the aggregates and release additional microcrystals of average particles of size 0.4 micron

17、. Crystallites of cellulose obtained from cotton are likely to be larger in size, though those obtained from pulp derived from hard wood or soft wood do not differ much in dimension. GLOBAL SCENARIO Major global manufacturers include the following Name of the Producer Location Microcystalline Cellos

18、e Powder Global and Indian Scenario Page 5 Ashai Chemical Industry Co. Ltd., Japan Blanver Farmoquimica Ltd. Brazil FMC Corporation USA/Ireland JRS Pharma Co. USA, Finland, Germany Ming Tai Chemical Co., Taiwan Wei Ming Pharmaceutical Mfg. Co. Ltd. Taiwan Aditivos y Farmoquimicos Mexico Alquimia Me

19、xicana, S. de R.L. Mexico Amrica Alimentos, S.A. de C.V. Mexico Central de Drogas Mexico Cia. Quimica Industrial Neumann Mexico Haiyan Liuhe Starch Chemical Co. Ltd. China Intercontinental Celulosa Mexico Dastech International, Inc. USA MCCP is currently being manufactured in most of the developed c

20、ountries (Avicel and Solka-Floc are trade names of typical MCC products) as well as in countries like China and India . In the USA, the FMC Corporation, Biopolymer Division is one of the large manufacturers of food grade MCC and its blends. FMC BioPolymer, an operating unit of FMC Corporation, has e

21、xpanded microcrystalline cellulose (MCC) production at the companys Newark, Delaware (US) plant recently. Global demand for MCCP : Around 50,000 metric tonnes per annum Microcystalline Cellose Powder Global and Indian Scenario Page 6 Global Demand/Supply Pattern Food and dietary / neutraceuticals 4

22、0% Pharmaceutical 60% GROWTH RATE IN DEMAND The demand for MCCP in pharmaceutical sector would be driven due to the shift of ethical drugs to the OTC market and by the increasing number of controlled release formulations MCCP is used as a fiber source, bulking agent and non caloric fat replacer. Dem

23、and from the food market is being driven by fat replacement applications. Likely growth in global demand: Around 3% per annum INDIAN MANUFACTURERS OF MCCP Indian manufacturers include the following Reliance Cellulose Products Ltd., Andhra Pradesh NB Entrepreneurs,Maharashtra Ashok Alco Chem Ltd, Guj

24、arat Accent Microcell Industries, Gujarat Alok Cellulose Products,Maharashtra Patel Industries, Gujarat Maple Biotech Pvt Ltd,Maharashtra Vikaash Chemicals, Tamil Nadu Sigachi Chloro Chemicals (P) Ltd., Andhra Pradesh Microcystalline Cellose Powder Global and Indian Scenario Page 7 Demand At presen

25、t, most of the demand for MCCP in India is confined to the pharmaceutical sector for tablet formulations. Many tablet manufacturers use MCCP in tablet formulations. The consumption level of several individual units are small in the region of 500 kg to 1000 kg per annum of MCCP. There are also large

26、consumers who consume in the region of 20 to 30 metric tonnes per annum The demand level for MCCP in pharma sector and food sector Around 3000 metric tonnes per annum Sample of Imports in India Period: 2008 Country Quantity in metric tonnes Port Period Ireland 51.800 JNPT 06.01.2008 to 08.01.2008 US

27、A 105 JNPT 06.01.2008 to 08.01.2008 Ireland 17.500 JNPT 09.01.2008 to 11.01.2008 Germany 1.200 Chennai March 2008 Taiwan 7 Chennai March 2008 Ireland 87.500 JNPT 01.03.2008 to 07.03.2008 Germany 22.800 Mumbai 01.04.2008 to 30.04.2008 Netherland 0.1 Chennai May 2008 IE 7.2 Chennai May 2008 Taiwan 12.

28、4 Chennai June 2008 Italy 0.25 Chennai July 2008 Ireland 14.400 Chennai July 2008 China 0.2 Chennai September 2008 Australia 0.5 Chennai September 2008 Taiwan 11.5 Chennai September 2008 Taiwan 12.4 Chennai September 2008 Ireland 35 JNPT 11.10.2008 to Microcystalline Cellose Powder Global and Indian

29、 Scenario Page 8 15.10.2008 Taiwan 11.500 JNPT 11.10.2008 to 15.10.2008 Taiwan 11 JNPT 08.10.2008 to 10.10.2008 IE 7.2 Chennai November 2008 IE 7.2 Chennai November 2008 China 0.1 Chennai November 2008 IE 2.16 Chennai November 2008 IE 8 Chennai November 2008 Australia 0.25 Chennai December 2008 Mex

30、ico 0.2 Chennai December 2008 Karachi 0.11 Chennai December 2008 IE 5.76 Chennai December 2008 IE 7.2 Chennai December 2008 Taiwan 3.840 Mumbai 01.12.2008 to 31.12.2008 Period: 2007 Country Quantity In metric tonnes Port Period USA 32.500 JNPT 02.01.2007 to 08.01.2007 Denmark 4.4 Chennai February 20

31、07 China 2.5 Chennai February 2007 China 1.875 Chennai February 2007 Karachi 0.2 Chennai March 2007 Ireland 14.500 JNPT 01.03.2007 to 07.03.2007 USA 35 JNPT 01.03.2007 to 07.03.2007 Ireland 50.120 JNPT 01.04.2007 to 05.04.2007 Karachi 0.2 Chennai May 2007 IE 7.2 Chennai May 2007 SE 0.3 Chennai June

32、2007 SE 0.025 Chennai June 2007 Taiwan 3.5 Chennai June 2007 Germany 4.800 Mumbai 01.06.2007 to 30.06.2007 Ireland 52.500 JNPT 04.08.2007 to 07.08.2007 Microcystalline Cellose Powder Global and Indian Scenario Page 9 Belgium 17.500 JNPT 08.10.2007 to 10.10.2007 Ireland 49 JNPT 08.10.2007 to 10.10.2

33、007 Mexico 0.55 Chennai October 2007 Taiwan 11.5 Chennai November 2007 Germany 12 Mumbai 01.12.2007 to 13.12.2007 Sample of Exports Country Quantity In metric tonnes Port Period Ghana 2.900 JNPT 04.03.2008 to 05.03.2008 Mexico 6 JNPT 01.04.2008 to 02.04.2008 Egypt 3 JNPT 01.08.2008 to 05.08.2008 Nig

34、eria 1 JNPT 01.09.2008 to 03.09.2008 Germany 0.280 JNPT 07.10.2008 to 08.10.2008 Thailand 12 JNPT 01.10.2008 to 06.10.2008 Kenya 0.500 JNPT 01.11.2008 to 03.11.2008 Nigeria 1 JNPT 01.02.2007 to 03.02.2007 Yemen Democratic 0.200 JNPT 01.02.2007 to 03.02.2007 Bangladesh 1.100 JNPT 07.03.2007 to 10.03.

35、2007 Kenya 0.100 JNPT 06.06.2007 to 08.06.2007 Kenya 1 JNPT 01.08.2007 to 02.08.2007 Togo 1 JNPT 06.08.2007 to 08.08.2007 Nigeria 0.025 JNPT 10.09.2007 to 11.09.2007 Microcystalline Cellose Powder Global and Indian Scenario Page 10 NANDINI CHEMICAL JOURNAL Published by NANDINI CONSULTANCY CENTER Gl

36、obal Information Source for Chemical, Pharmaceutical and Allied Industries Nandini Chemical Journal is a monthly journal covering the developments in Indian and global chemical industry with insight and analysis. To subscribe to the journal, or to receive a free monthly newsletter of Nandini Chemica

37、l Journal, please visit our website For general enquiries and information on how to advertise in the journal, please contact Mr. V. Jagadeesan, +91-44-24461346, Nandini Consultancy (S) Pte. Ltd. 105, Cecil Street, 0601, The Octagon, Singapore 069534 T: +65-6827 4511 F: +65-6827 9601 Nandini Consultancy Center Pvt. Ltd., M60/1, 4th Cross Street, Besant Nagar, Chennai 600 090 India T: +91-44-24461346 F: +91-44-24916037

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