Dextromethorphan HBr has been in tight supply since mid to late October 2010. Most of the supply chain is on allocation and in some cases only contract customers are getting inventory. According to one manufacturer there are two key issues related to the shortage. First the world wide demand for Dextromethorphan has increased toward the end of CY 2010, and secondly manufacturers kept their inventory levels lower than normal because of the uncertainty of the future OTC status of Dextromethorphan in the USA . It seems likely that this shortage will continue for several months.
PleraSan CH is a 1,3/1,6 D beta glucan while oat glucans have a molecular structure of 1,3/1,4 D beta glucan. Plerasan CH is an immunomodulator which activates the Langherans cells in the epidermis leading to increased immune activity. When the Langherans cells are activated cytokines are released which communicate with fibroblasts. Fibroblast communication results in increased production of chondroblast, collagenoblast, and osteoblast cells.
Oat glucans do not have any immunomodulating properties and do not activate Langherans cells in the epidermis. PleraSan CH has excellent sensory properties with good physico-chemical stability. Oat glucans have a tendency to provide off notes resulting in a beer like smell in the cream and on the skin after use. Yeast glucans have a similar molecular structure to PleraSan CH but have to be carboxymethylated in order to make them soluble which can compromise activity level. PleraSan CH is a water stable product which does not have to be rendered soluble like the yeast glucans.
Plerasan CH can be pre-dispersed in the water phase, before emulsifying or it can be added after the water phase after emulsification has occurred at a temperature below 60°C. The recommended usage level for PleraSan CH is between 2% and 10%.
AIC and Tournay Biotechnologies are proud to announce the joint sponsorship of the SupplySide Connect website for the 2010 SupplySide West exposition. With over 1,200 booths for ingredient suppliers, service providers and technology innovations; SupplySide West is the largest meeting place for the exchange of ideas for the food, beverage, nutraceutical and cosmeceutical industries. Through the SupplySide Connect Search, attendees can search for ingredients, exhibitors, products and brands being showcased at this exhibition. Consumers interested in natural extracts, powders and specialty ingredients, will have easy access to the innovative offerings from AIC and Tournay through our specialty website (www.aicma.com/tournay/ssw) by simply clicking on the body of the flash advertisement on SupplySide Connect.
Supriya Life Science has filed a US DMF for Brompheniramine Maleate and was given the following DMF # 23511. For any technical data or DMF reference number please contact AIC.
BENEO GmbH Enters Japan With Multifunctional Bulk Excipient
The manufacturer BENEO, member of the Südzucker Group, recently announced that the Pharmaceutical and Medical Devices Agency (PMDA) in Japan has granted the first license for the manufacture and distribution of a pharmaceutical product utilizing the benefits of galenIQ. Having already been approved in the US and Europe, the granted license is seen as a reference approval for galenIQ in Japan.
“We are delighted to be present with galenIQ in one of the most important markets for the pharmaceutical business,” said Bodo Fritzsching, Head of Sales & Technical Services PHARMA. “The approval is a considerable step forward for galenIQ since its launch in 2005, and confirmation of the product’s technological and physiological properties. Because manufacturers located in Japan as well as global manufacturers with international drug formulations can now benefit from galenIQ, we are confident that more market products will follow.”
galenIQ (pharmaceutical grade isomalt) is available in different grades. All grades are characterized by their very low hygroscopicity, excellent chemical and physical stability, as well as their technological benefits. The multifunctionalexcipient especially facilitates the development and formulation of specific solid-dosage forms, such as tablets, sachets,capsules, coatings, or lozenges. galenIQ is a white, odorless, water-soluble, crystalline substance of non-animal origin and GMO-free. Furthermore, it shows a low glycemic response and is non-cariogenic.
The multifunctional excipient combines the advantages of other well-known fillers and binders. Manufactured in different grades, it is used in a very wide range of different solid dosage forms. The galenIQ range includes grades 720 and 721, which are excellent filler/binders for direct compression and powder mixture applications, and the 800 series, which offers special ground grades for wet granulation, compaction, and other agglomeration processes. Besides its application in granulation, galenIQ 801 is used as a co-polymer in film-coatings to improve film adherence and reduce coating time. The 900 series is highly suitable for capsule fillings, sachets, sugar-free coatings, and high-boiled lozenges.
galenIQ is listed in the US FDA’s inactive ingredient database under its generic name Isomalt. It complies with the isomalt monographs of the current Ph Eur, BP, and USP-NF. BENEO-Palatinit is a member of the International Pharmaceutical Excipients Council, and produces galenIQ under cGMP conditions for pharmaceutical excipients.
Vitamin D3 Water Soluble 100IUmg from Supreem Pharmaceuticals has just been granted DMF # 23749. Supreem Pharmaceuticals Mysore Pvt Ltd is one of the leading providers of a wide range of bulk stabilized vitamins, minerals & nutraceuticals. This form of Cholecalciferol is freely soluble in water and will form a clear solution in water.
Check out the Natural Products Insider article about carotenoids. “Carotenoid Color Wheel of Health” This article is a great educational piece and reference for all carotenoids. We are also very proud of the contributions from Matteo Zema and the technical staff at Vitatene for this article.
There are plenty of products on the market that tout their impact on the functional capacity of the immune system. But how many of them can make the claims of efficacy in multiple clinical studies involving human subjects, the proven safety and consumer acceptance shown by over ten years in consumer products and is isolated from natural, GMO free and allergen free raw materials? Imunoglukan P4H® certainly can.
Imunoglukan P4H® is the trade name for beta-(1,3/1,6)-d-glucans derived from oyster mushroom (Pleurotus ostreatus). This compound also is also scientifically identified by the name “Pleuran”. Identification and processing developments associated with this compound were established by scientists in the 1980′s, patents relating to the compound were filed in the 1990′s and the company Pleuran s.r.o. was established in 2000 to manufacture and develop marketing and sales for this compound. With the launch of the Europe’s first consumer product containing Imunoglukan P4H® in 2001, numerous clinical trials conducted with this compound over a ten year period, and multiple product launches since Imunoglukan P4H®has becomed positioned as the leading immuno-modulation nutraceutical product in Europe.
The mechanism of action for beta-(1,3/1,6)-d-glucans in the human system when ingested can be divided into a few simple steps. As the insoluble molecule of Imunoglukan P4H® passes through the intestines, it will come into contact with small sensors called Peyer’s Patches. These Peyer’s Patches are a collection of lymphoid tissue in the lower intestines that play a part in the immune system by identifying pathogenic organisms and communicating to the rest of the immune system to initiate an appropriate response. Peyer’s Patches also have receptors that identify beta-(1,3/1,6)-d-glucans specifically and will initiate communicate to the rest of the immune system upon identification of this compound. The immune system will then react by initiating an immune response as if it is preparing for potential attack from pathogens.
Clinical trials conducted with healthy human subjects using Imunoglukan P4H® have shown three other important factors. 1. The parameters used to measure efficiency of the immune system are elevated when taking Imunoglukan P4H®, though not beyond levels that are considered normal. 2. The body’s immune system does not develop a dependency on Imunoglukan P4H® to maintain healthy immune function, so when one stops taking Imunoglukan P4H® there is no threat of decreased immune function. And 3. Studies conducted on representative groups including healthy human adults and children as well as domestic animals have shown efficacy and safety for the use of this ingredient across many application ranges.
The clinical studies, along with the presence of numerous consumer products for human and animal nutrition available in the European market for the past decade, provide further evidence to promote the safety and efficacy of this ingredient as a valuable immuno-modulation supplement. Imunoglukan P4H®, when wellness matters.
For information and samples contact sw@aicma.com or visit www.aicma.com.
AIC is proud to announce our participation in the SupplySide East at the Meadowlands Exposition Center in Secaucus, New Jersey on April 27th and 28th. At booth #1421, AIC will have eastern US sales representatives and technical staff on site to answer questions about our innovative ingredients including soluble minerals, cranberry, pomegranate and other extracts, immuno-modulators, natural colors, flower pollen extract, maqui berry extract and others. Manufacturer representatives from Supreem (cold water dispersible Vitamin D3) and Vitatene (natural Beta Carotene, Lycopene and Lutein) will also be on hand to offer their expert insight into their ingredients. Keep with our tradition at tradsshows, AIC will have beverage samples available to demonstrate the effectiveness and ease of formulations with our ingredients. We invite you to stop by booth #1421 to taste and see the difference that we can make in your products.
Vitamin D3 (also known as Cholecolciferol) has generated a lot of great buzz lately in formulation circles, and consumer awareness of this ingredient is increasing exponentially due positive press associated with recent studies involving this ingredient. Research studies from highly respected organizations have theorized this ingredient to have potential impact on a wide variety of health conditions including immunomodulation, various forms of cancer, cardiovascular disease and mortality. Further generating positive press was the US Food and Drug Administration’s amended health claim on calcium and 
osteoporosis, which now includes vitamin d. This new ruling removed many of the historical limitations associated with the claim and specified the ability to clarify the role Vitamin D plays in the body’s ability to absorb calcium. Though this ruling did not became effective until January 1, 2010, manufacturers were permitted to use the claim as early as September 2009.
AIC is proud to be partnered with Fermenta Biotech and Supreem Pharmaceuticals to offer a Vitamin D3 to product developers in the US in a variety forms to meet their specific formulation requirements.
Supreem Pharmaceuticals, India’s most reputed company in the field of Stabilized Vitamins, uses proprietary processing techniques to manufacture Vitamin D3 in cold water dispersable and coated forms for numerous applications.
Fermenta Biotech, India’s first and still the only manufacturer of Vitamin D3, uses over 25 years experience to bring the highest quality, highest purity Vitamin D3 to discerning finished product managers worldwide.
Vitamin D3 and AIC – Many practical applications, one logical source.
For more information and samples contact info@aicma.com or visit www.aicma.com.