Effer-Soda® Surface Modified Sodium Bicarbonate

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Effer-Soda®Effer-Soda® is a highly stable, surface modified sodium bicarbonate powder developed for use in pharmaceutical and nutraceutical applications. It addresses the challenges formulators face when working with effervescent applications by removing trial and error. Effer-Soda helps formulators to develop stable effervescent formulations regardless of packing forms.

Surface Modification Provides ProtectionSodium bicarbonate is a primary ingredient in effervescent tablets and powders. Together with an acid, such as citric acid or tartaric acid, sodium bicarbonate reacts in the presence of water to produce carbon dioxide (CO2). Consequently, the major disadvantage of sodium bicarbonate is that, in the presence of minute amounts of moisture and acid, it immediately effervesces. This reactivity can lead to formulation instability and premature effervescence on stability and storage. Also, additional processing steps to pre-dry the powder along with special equipment and processing conditions are required during manufacture in order to avoid premature effervescence.

This issue can be resolved using Effer-Soda, which provides enhanced stability to effervescent formulations. This is achieved by converting the appropriate amount of sodium bicarbonate to the sodium carbonate. The converted sodium carbonate acts as a desiccant skin, preventing premature effervescence.

Enhanced StabilityWith Effer-Soda, you get total protection. A physical mixture of sodium carbonate, sodium bicarbonate cannot achieve results similar to Effer-Soda. Since sodium carbonate is not present throughout the tablet, there are local areas of contact between sodium bicarbonate and acid. If there is the presence of a slight amount of water, the formulation will effervesce and produce additional water. This will eventually create stability issues. But with Effer-Soda, each particle is surface modified to prevent an early reaction.

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Product Sales Bulletin

Effer-Soda Advantages¥¥ Manufactured in a dedicated

pharmaceutical facility under cGMP guidelines¥¥ Effer-Soda has US DMF Type IV¥¥ Free flowing highly stable powder¥¥ Effer-Soda is directly compressible¥¥ Improves finished product

stability by eliminating premature effervescence¥¥ Provides rapid effervescence when

desired in the presence of large amounts of water¥¥ Reduces need for humidity

controlled manufacturing environment¥¥ Reduces manufacturing steps by

eliminating the need to pre-dry effervescent powder¥¥ Supported by SPI Pharma global

team of technical experts

APPLICATION PERCENT OF EFFER-SODA USED

Organoleptic enhancement in orodispersible systems 1 - 4% of formulation

Effervescent system within tablet or sachet 15 - 25% of formulation

pH buffering within formulation (no acid added) like floating drug delivery system 5 - 25% of formulation

Variety of Packing OptionsTo differentiate the finished formulation, Effer-Soda offers you a variety of packaging options. Using sodium bicarbonate, the formulation needs to be packed in a tube pack with a desiccant. However, an effervescent formulation using Effer-Soda can be used in the strip, blister and sachet packaging options, helping the formulator differentiate their product in the market.

Additional ApplicationsBeyond uses in effervescent tablets and sachets, Effer-Soda can provide effervescence within a chewable or fast disintegrating system to improve organoleptics and taste profile. Micro environmental pH modification improves the release of weakly acidic drugs.

Better Compaction and Excellent Flow PropertiesEffer-Soda is ideal for direct compression and sachet formulations compared to sodium bicarbonate. It has better compaction, allowing for less binder, resulting in an exceptional effervescent tablet. With a superior Carr's Index, Effer-Soda has an excellent flow compared to sodium bicarbonate.

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Effer-Soda 12Sodium CarbonateSodium Bicarbonate

AmericasSPI Pharma, Inc.Rockwood Office Park503 Carr Rd., Suite 210Wilmington, DE 19809

Europe/Middle East/ AfricaSPI Pharma SASChemin du Vallon du Maire13240 Septemes-Les VallonsFrance

Asia/PacificSPI Pharma, Inc – India Branch21 B, Veerasandra Industrial AreaHosur Road, Bangalore – 560100Karnataka, India

Australia Distribution CompanyAnzchem1 Braidwood StreetEnfield NSW 2136Australia

Contact Us:salesinfo@spipharma.com

www.spipharma.com

© SPI Pharma 2016. All trademarks are the property of SPI Pharma. The information contained in this document is proprietary to SPI Pharma and may not be used or disseminated inappropriately. The information and recommendations contained herein are to the best of SPI Pharma, Inc.’s knowledge reliable and accurate. Any recommendations are made without warranty, either implied or expressed, due to the variations in equipment, conditions, and methods which may be used in commercially processing the products. No warranties of any kind are made, express or implied, including those of merchantability and fitness for particular purpose, other than the products conform to current standard specifications. SPI Pharma, Inc. makes no warranty that the use of the products or formulations provided by SPI Pharma, Inc. will not infringe any trademark, trade name, copyright, patent or other rights held by any third party when used in customer’s application. SPI Pharma, Inc. shall not be liable for loss of profit or for incidental, special or consequential loss or damages.

Order No. SPI-EXC-EFF-0100-08201601 09-2016 | All rights reserved

Effer-Soda®Typical Properties*

*Typical properties not intended to be product specifications.

Description A white, free flowing crystalline powder

Mean Particle Size (D50) 200 µm

Bulk Density 1.01 g/mL

Tapped Density 1.22 g/mL

Flow/Carr’s Index Approx. 17

Sodium Carbonate 8-12%

pH 8.9-9.2

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