Effer-Soda®

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Product Information

Effer-Soda is a highly stable, surface-modified sodium bicarbonate powder developed for use in pharmaceutical and nutraceutical applications. Particles are surfaced modified with sodium carbonate to act as a protectant layer. It increases resistance to humidity and prevents premature effervescence, helping formulators to develop stable effervescent formulations regardless of packing forms. Products formulated with Effer-Soda require fewer binders. The is ideal application is effervescent tablets.

The Effer-Soda manufacturing process ensures that each particle of Sodium Bicarbonate is surface modified with Sodium Carbonate. Each particle must be surface modified to prevent contact of water or hydrated acid with the sodium bicarbonate, in order to avoid premature effervescence in both effervescent tablets and effervescent sachets

Benefits at a Glance: 

• Particles are surface modified with sodium carbonate to act as a protectant layer
• Increases resistance to humidity and prevents premature effervescence
• Lower failure rate
• Microenvironmental pH modification improves the release of weakly acidic drugs
• Quick effervescence is possible when desired
• ~200 PSD D50 (μm)

Formulation Protection Testing

10g samples placed in sachets;  Conditions:

• 54% Sodium carbonate, Effer- Soda, or Sodium bicarbonate
• 46% Citric acid monohydrate
• Heated to 45-50 °C

2 Hours Later – Packaging checked for ballooning, you can see there is significant ballooning in the package formulated with sodium bicarbonate alone.

Compactibility Test

70% Effer-Soda, Sodium carbonate or Sodium bicarbonate; 30% Mannogem EZ; Compacted to 10, 20, and 30 kN; 1000mg tablets compressed using 0.625” FFBE “D” punch on Lloyds Press

Starting Point Effervescent Formulation for increased stability

Effer-soda® can be used in combination with Mannitol binder. SPI Pharma offers Powdered, Granular, and Spray dried Grades.
A typical example of an effervescent tablet using Effer-soda® is listed below. The type of active used here varies based on the API dosage. This can be replaced by a Nutraceutical active such as Vitamin C.

Other key factors to consider:

1. Type of acid can affect Taste, Reactivity time/Dissolution, and Tablet compressibility.
   • Citric acid carries a strong citric-like taste whereas Malic acid has a smooth aftertaste.
   • Adipic and Fumaric acid have slow reactions due to solubility.
   • Citric acid is hygroscopic and very malleable upon compression which leads to sticking.
   • Tartaric and Ascorbic acid (Vit C) can act as self-lubricants in tableting.
   • Choosing crystalline forms of the acid can help with lubrication and sticking.
2. The ratio of Acid to bicarbonate source. The Effer-soda®: Acid ratio will have an impact on reaction time as well as the final pH of the liquid medium. This ratio can be adjusted or switch acid sources to produce the desired effervescent performance.
3. Binder choice affects the relationship between porosity, strength, and disintegration time. Ideally recommend to use a binder that is readily soluble, non-hygroscopic, and pleasantly sweet. In addition, it offers appropriate robustness to overall formulation i.e. compressibility, tablet hardness vs. porosity, and meets a disintegration limit of under 3 mins.
   Recommended choice of binder: SPI’s Spray-dried Mannitol (Mannogem EZ, XL, XL Opal) or Granular grade Mannitol Mannogem XL Ruby
4. Lubricant and surface-active materials -optional/dependent on the formulation
5. Process choice and environmental consideration

Additional Applications of Effer-Soda

• Fast-dissolving and chewable tablets for taste masking and organoleptic enhancement
• Swallow tablets/Dispersible powders to modify drug pH or increase the rate of release in weakly acidic drugs

Looking for the same functionality for a Nutraceutical product, check out the Effer-Soda 8!