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Technical Support

Sigachi has extensive experience in formulation and processing. When customers use HiCelTM, they get the benefit of this unparalleled experience, in the form of exceptional technical support.

Sigachi’s technical service professionals perform a number of essential tasks for customers, including conducting functionality, stability, and other tests, helping customers find solutions to their processing problems. We are also conducting seminar for customer.

Sigachi and our Technical Service Staff are always available to find the solution to your many technical challenges.

For further information on Sigachi’s outstanding products and services, contact us at e-mail centre@sigachi.com or go to our website at

solutioncentre@sigachi.com or go to our website at www.sigachi.com.

Available for our products supporting documentation

Sr.No. Supporting Documentation
01. EXCiPACT GMP
02. Manufacturing License No.
03. cGMP Certificate
04. WHO GMP Certificate
05. CEP certificate from EDQM-France
06. DMF with USFDA
07. ISO 9001-2015
08. Food Safety System Certification 22000
09. Food facility registration
10. Environment Operating License
11. Kosher Certificate
12. Halal Certificate
13. Specification Sheet
14. Technical Data Sheet
15. Safety Data Sheet
16. Certificate of Analysis

Manufacturing Facility

We have in house manufacturing facilities with all the state of the art modern technologies to meet the highest standards of product quality. Our manufacturing facilities are backed up by highly qualified technocrats provides optimum customer satisfaction. All processing areas are provided with 3 filtered air and final product packing area is supplied with 0.3 HEPA filtered air through dedicated Air Handling system.

Quality Facility

The Quality Assurance and Quality Control units were independent from the production.

Our Quality control department is responsible for approval of raw materials, packaging materials and finished products against approved quality specifications.

The documentation system was maintained and reviewed according to the quality policy in the written procedure. Documents with product quality relevance were approved by the Quality Assurance.

Sigachi has state-of-the-art R&D facility to develop the quality of existing products and also new molecules in other segments .The R & D facilities are approved by Government of India, Ministry of Science & Technology, Department of Science and Industrial Research. Sigachi has dedicated pool of M.Pharm & doctorate who continuously work on new products processes & innovations. Sigachi has fully equipped laboratory with high-tech advanced instruments and highly qualified technical personnel at its R & D centers.

Its advanced Analytical Instruments include:

Sr.No. Name of Instument
01. Tablet Making Machine
02. Dissolution Apparatus
03. Hardness Tester
04. Viscometer
05. Stability Chamber

Brief Process Description, in process control and batch release system

Sigachi Pharmaceuticals grade microcrystalline cellulose

We manufacture 36 grade of microcrystalline cellulose and we meet stringent international standards of quality.

Thats the Sigachi benchmark.

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HiCelTM Overview

HiCelTM can be produced by controlled hydrolysis of a-cellulose with the dilute inorganic acid solution, and a-cellulose can be obtained from the plant fibers containing cellulose pulp. Hydrolyzed cellulose can form the dry porous particles with a wide particle size distribution by filtration, purification, and water slurry spray drying. Most commercial grades are formed by varying and controlling the spray drying conditions in order to manipulate the degree of agglomeration (particle size distribution) and moisture content (loss on drying).

HiCelTM is generally considered as the diluent having the best binding properties and is recognized as one of the preferred DC binders In addition to its dry binding properties, and in comparison to brittle excipients, HiCelTM is self-disintegrating with low lubricant requirement due to its extremely low coefficient of friction and its very low residual die wall pressure

However these properties do not replace the need for true disintegrants and lubricants when HiCelTM is used in a formulation. In fact HiCelTM and superdisintegrants may be complementary to promote fast disintegration.

Standardization of HiCelTM/AceCelTM

HiCelTM/AceCelTM complies with the latest editions of United States Pharmacopeia - National Formulary/ European Pharmacopoeia, British Pharmacopoeia, Japanese Pharmacopoeia, Chinese Pharmacopoeia and Indian Pharmacopoeia

Product Description

HiCelTM /AceCelTM is purified and partially depolymerised a-cellulose and relatively free from both organic and inorganic contaminants. White or almost white, fine or granular powder. It consists of free flowing, non fibrous particles. The raw materials, manufacturing process, and product do not contain any of the solvents listed in the residual solvents (Ph.Eur. <5.4>, USP<467>).

Packing and Storage

Store at ambient conditions and Preserve in tight containers. The Standard packing is 20kg paper bags with double polythene liner and this product is also available in 25 kg HDPE bags with double polythene liner, 25kg drums with gazette liner, 15kg carton box with double polythene liner upon request.

Application

The HiCelTM is a widely used excipient, an inert substance used in many pill and tablet formulations. As an insoluble fiber, HiCelTM is not absorbed into the blood stream, so it cannot cause toxicity when taken orally.

The HiCelTM is mainly used in the pharmaceutical industry as a pharmaceutical excipient, and compared with the starch or starch derivatives have the following advantages.

    1). The HiCelTM is easy to disintegrate, that is, after entering into the stomach the drug can be easily disintegrated and then absorbed by the body.

    2). The HiCelTM is difficult to get moldy. This is because the cellulose is -glucose configuration while the starch is a-configuration. Amylases generally do not attack the cellulose.

    3). The HiCelTM is not absorbed by the body and is not easy to react with carrying drugs, and therefore more secure.

1. In the Pharmaceutical Industry

It is often used as adsorbents, suspending agents, diluents and disintegrating agents. The HiCelTM is widely used in the pharmaceutical preparation, mainly as diluents and adhesives in oral tablets and capsules. It can be used for wet granulation as well as direct compression by dry method. It has some lubrication and disintegration action so is very useful in tablet preparation.

Concentration of HiCelTM used in formulation:

Now-a-days the HiCelTM is used in Pharma with different concentration as follows:

Sr.No. Use Concentration (%)
1. Adsorbent 20-90
2. Antiadherent 5-20
3. Capsule binder/dilutent 20-90
4. Tablet disintegrant 5-15
5. Tablet binder/dilutent 20-90

Our Process is validated and gives consistence results in terms of Friability, Weight variation and Hardness which is very beneficial to pharmaceuticals Formulation Company.

Following graph indicate the quality of our product:

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The above profile is for the tablets having 100% HiCelTM. From the above graph it is observed that the friability and weight variation is within the Pharmacopeial limit and Hardness is also good enough for tablet. After using other ingredients in the tablet it is likely that hardness will be better.

2. In the Food Industry

In the food industry, HiCelTM/AceCelTM can be used as an important base in functional foods and is an ideal health food additive.

1). It can maintain emulsification and foam stability.

2). It can maintain high temperature stability.

3). It can improve the liquid stability.

4). It can act as nutritional supplements and thickeners.

In dairy products, HiCelTM/AceCelTM can prevent sedimentation of insoluble particles and re-agglomeration of fat particles to achieve stable results. Association with milk protein will not occur. It can be compounded with other stabilizers in high calcium milk, milk drinks and cocoa milk to form a thermally stable network and to play the suspension stabilizing role at low viscosity.

Since HiCelTM/AceCelTM is obtained by hydrolysis of cellulose, it has the features of not being digested by the body as well as promoting the intestinal peristalsis, and is a good low-energy food additive.

In frozen food, HiCelTM/AceCelTM can not only improve the foam stability and emulsifying properties of frozen food, but also can effectively prevent the growth of ice crystals so that the frozen food can have a soft and smooth taste.

HiCelTM/AceCelTM is widely used as gelling agent, stabilizer, anti-caking agents and suspending agents in beverage. HiCelTM/AceCelTM to improve the stability of liquid in instant beverage.

HiCelTM/AceCelTM is improving the stability in ice cream, frozen food, canned meat and condiments to improve the stability as a hot and cold stabilizer

HiCelTM/AceCelTM act as a anti-caking agent and improve water retention and reduce food calories in baking goods.

HiCelTM/AceCelTM act as a fat substitute and emulsifier and increase the viscosity and reduce fat in ice cream, low-fat meat products and condiments.

3. In Cosmetics

As an ingredient, Cosmocel can be used in the production of various kinds of cosmetics, skin care and treatment products, and detergents. Cosmocel is widely used as fat substitute, thickener, and binder in Cosmetics.

As fat substitude and thickener: in cosmetic and personal care product to keep stable quality and fresh. As Binder: in facial cosmetics to be smooth and easy to wipe out.

As Spreading agent: Improves the ease of spreading on skin /hair and increase the homogeneity of distribution of the cosmetic preparation.

More improved grades can be expected in the coming future that will directly impact the products quality and performance attribute.

The content of solution centre is based on our R&D work .Feel free to contact us if you have any questions about HiCelTM/AceCelTM and Cosmocel.