Sallyso – Croscarmellose Sodium (CCS) by GANGWAL Healthcare
GANGWAL Healthcare Pvt. Ltd., part of the prestigious Gangwal Group, has been a pioneer in the Pharmaceutical industry since 1987. Driven by the sense of social wellbeing and the steely determination to make a difference through technology and expertise, Gangwal Healthcare continues to be at the forefront of Pharmaceuticals, Nutraceuticals and Personal Care sectors in India. Nutraceutical industry globally, is a fastest growing market. As per the recent reports, India has remained 2% of the global nutraceutical industry of USD 400 billion and has potential to be a USD 50 billion by 2025 and USD100 billion by 2030. Our people are our core asset. Their vision, their ideas, their formulations, all connected at the core of Gangwal’s success. The team turn our formulations into reality. A reality that has made
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Sallyso – Croscarmellose Sodium (CCS)
The effective superdisintegrant
Sallyso® – Croscarmellose Sodium (CCS) is an cross-linked Carboxymethylcellulose-Sodium, and it is water-insoluble, yet rapidly swelling and absorbing in water. As a result, it provides excellent tablet disintegration and dissolution of the APIs, thus ensure the better bioavailability.
Sallyso® provides consistent disintegration performance which helps to the low use level of CCS for excellent disintegration and dissolution.
Benefits of Sallyso®
- Fast disintegration
- Better dissolution
- Excellent bioavailability of active ingredient
- No effect on the compression and flow
- Cost-effective as it used in less percentage (0.5-3.0% only)
Sallyso (CCS) provides excellent dissolution properties in tablet formulations. Standard use levels are between 0.5-3.0%. in tablets, capsules and granules for disintegration and dissolution improvement.
Effect of Sallyso on Tablet Disintegration
Dicalcium Phosphate (DCP) tablets are poorly disintegrating, we have compared different levels of CCS and their effects on disintegration time on DCP tablets as shown below table.
Croscarmellose Sodium%
0.10
0.25
0.50
1.00
1.50
Disintegration Time
>1.8 Hrs
240 sec
30 sec
17 sec
15 sec
Effect of Settling Volumes in Sallyso® in Dissolution
Products having Sallyso® with higher settling volume has faster drug dissolution. It helps in faster drug release rate.
Physical properties
Croscarmellose Sodium (CCS) is a effective superdisintegrant used in tablet and capsule formulations at 0.5–3.0% w/w concentration.
Physical Properties
Bulk density (g/mL)
Tapped density (g/mL)
Settling Volume
Result
0.51
0.56
13 – 18 ml/g
Particle size (by Malvern)
Parameters
d10
d50
d90
Specification
<25 µm
25-60 µm
>60 µm
Experimental Section
Sallyso® can be used in wet granulation, dry granulation or direct compression. It is compatible with most of APIs and excipients. Sallyso® give superior performance compared to many other Croscarmellose Sodium brands.
Metformin Direct Compression formulation
Name of Ingredient
Metformin
ProBlend HD
Croscarmellose Sodium
Sodium Stearyl Fumarate
Total
Quantity (% w/w)
70.8
26.6
2.1
0.5
100.0
Experimental Section
Direct compression study
Sallyso® In direct compression standard use levels is between 0.5%-3.0%. Table 1 shows How the disintegration time of Metformin tablets (850 mg / 15 mm) tablets containing 2.1%w/w Sallyso® and 0.5%w/w Sodium Stearyl Fumarate is maintained after storage for 6 months at 40˚C / 75% RH in open container. The disintegration of reference tablets is also comparable with leading CCS brand.
This data confirms that Sallyso® remains an effective super-disintegrant even under the most stressful stability storage conditions when it is compared with leading CCS brand.
Performance & Conclusion
Parameter
Punch
Hardness
Thickness
MCF
DT
Competitor-D CCS
15.00 mm
45 N
5.60-5.65 mm
4.00-4.3 kgf
7.5 sec
Sallyso
15.00 mm
55 N
5.60-5.65 mm
4.3-4.8 kgf
8 sec
Performance & Conclusion
Accreditation & USP
Advantages over overseas product
Customized settling volume, particle size, bulk density & surface area.
Cost effective over overseas product.
Easy to access our manufacturing site and less expenses on compliance (Audit, site visit etc).
No need to maintain huge inventory, our product can be delivered to your site within a week.
Customized grade can be provided as per costumer’s in-house specification
Vocal for Local – Make in India product
Regulatory compliance
Sallyso® is manufactured at WHO-GMP and ISO certified facility.
Pharmacopoeia conformity: Sallyso® (Croscarmellose Sodium (CCS)) available in USP, BP, IP and Ph. Eur.
Ready tech pack in line with regulatory requirement.
Regulatory Approvals
Croscarmellose Sodium is also included in Inactive Ingredient database (IIG) of USFDA for Tablet, Capsule, Pellets, Suspension formulations. Our manufacturing unit is approved by WHO-GMP and ISO 9001 : 2008 Sallyso® is having Type IV Registered US-DMF.
See the full brochure on Sallyso (CCS) here
(click the picture to download the brochure)
Source: GANGWAL technical brochure Sallyso (CCS)