Effervescent excipients - surface-modified sodium bicarbonate has a registration number

The surface-modified sodium bicarbonate produced by SPI Pharma has obtained the CDE related registration number: F20200000255.

Effervescent dosage form

Effervescent tablet is a special kind of tablet, which uses organic acid and carbonate (hydrogen) salt to react as effervescent disintegrant.

The most prominent features of effervescent preparations are rapid disintegration and dissolution in vitro; rapid oral absorption; high bioavailability and remarkable curative effect

Other excipients: lubricant sodium stearyl fumarate , polyethylene glycol 4000 or 6000, etc.

Conventional preparation methods such as wet granulation, dry granulation, direct compression, non-aqueous granulation, etc.

Figure 1.

》As shown in Figure 1, Effer-Soda ^® surface-modified sodium bicarbonate produced by SPI has a good performance in preventing the sticking problem in the preparation process of effervescent agent, which is mainly due to the fact that it is not a simple sodium bicarbonate , but the modified sodium bicarbonate whose surface is processed into sodium carbonate, which can not only effectively prevent moisture and sticking, but also prevent the effervescent dosage form from prematurely absorbing moisture and producing carbon dioxide, resulting in unqualified product quality such as bag swelling.

1.

Composition: sodium carbonate 10%~17%, sodium bicarbonate 83%~90%

pH: 9.

Model: Effer-Soda ^®  12

2.

In effervescent tablets and effervescent pouches, each granule must be surface-modified to avoid premature moisture absorption and foaming; the Effer-Soda ^® production process ensures that each granule of sodium bicarbonate is treated with sodium carbonate Surface modification can effectively prevent the above problems

Below we use 2 experiments to verify

 》It can be seen from the above two tests that the effervescent tablets prepared by using surface-modified sodium bicarbonate can better prevent the quality problem of carbon dioxide generated due to moisture absorption during the production or preservation of the product.
This is because the surface of Effer-Soda ^® The sodium carbonate absorbs a small amount of moisture inhaled during the packaging process, avoiding the occurrence of the above phenomenon
.
The structural properties of Effer-Soda ^® allow pharmaceutical manufacturers to use it under normal humidity and temperature conditions
.

 》Adjusting the dosage of Effer-Soda ^® can adjust the drug release behavior
.
This is due to Effer -Soda ^® 's ability to adjust the pH of the microenvironment surrounding the tablet, improving drug release by releasing the ionized form of the weakly acidic drug
.
Incorporation of Effer-Soda ^® into oral tablets greatly improves drug release and absorption
.

5.
Better compressibility and flow

Compared to sodium bicarbonate, Effer-Soda ^® is ideal for direct compression and pellet bag assemblers
.
It has better compressibility and reduces the amount of binder, resulting in excellent effervescent tablets
.

^{Effer-Soda ®} has excellent compressibility and flow properties compared to sodium bicarbonate , see Figure 6 .

Summarize

Reasons to choose SPI Effer-Soda ^® Surface Modified Sodium Bicarbonate:

• 
  Has registration number F20200000255;

• 
  The surface is modified to effectively solve the sticking problem of the effervescent preparation process, so that effervescent preparations can be produced under normal temperature and humidity conditions, which is more conducive to large-scale production;
  

• 
  Good compressibility and fluidity;
  

• 
  Microenvironment pH adjustment brings better drug disintegration and release;

• 
  Better taste and user experience
  .