His presentation titled “Metabolic effects of guggulipid: results from a randomised controlled trial” will summarize the results of a recent trial with Sabinsa’s trademarked product.

Sabinsa Corporation supplies several herbal extracts as granules. These extracts are designed to facilitate the manufacture of finished dosage forms. In a 3-part series that will appear in consecutive issues of this letter, we present the science and technology behind granulation of herbal extracts.

The presentation begins with an introduction, in the current issue.
Many herbal extracts and herbs in raw form cannot be formulated directly to tablets or capsules because of one or more of the following reasons:

1. They do not have adequate bonding property to form a loose compact for capsules or compressibility and adhesion for tablets.
   
   
2. They do not ordinarily exhibit the needed flow on high speed machines
   
   
3. They may not have adequate bulk density to achieve filling in the capsule or in the die cavity in case of tablets.
   
   
4. They may contain materials with significant different particle sizes or different bulk densities leading to segregation in the machine hopper or in the blend. This will lead to non-uniform dosage form.

To overcome these problems granulation is a practical solution. Granulation is defined as any process of size enlargement whereby small particles are gathered into larger, permanent aggregates to render them into a free flowing state. Many processes can achieve this size enlargement. Most popular ways are wet granulation and dry granulation.

The choice of excipient is critical for efficacy of the product. Sabinsa helps in this stage of formulation and can give samples using various excipient options.

In the first part of this article we focus on wet granulation.:

Wet granulation can be done using different kinds of blenders. Typically these blenders should be high shear generating and should have positive moving arm or paddle or impeller. Sabinsa employs a Rapid Mixer Granulator for this process. The end point of the process can be determined based on torque as current drawn or adhesion of wet material or material movement in the mixe.

Sabinsa offers custom granulation using its own products or a customer’s product. The excipients are carefully chosen to meet the customer’s need and requirements. The product is processed in the presence of a pharmacist and is analyzed to ensure compliance for designed parameters.

Wet granulation as the name suggests involves use of solvent. It can be aqueous or non-aqueous granulation. A Liquid binder facilitates the bonding process. The bonding achieved in such granules is by adhesion and cohesion. Wet granulation is a popular and versatile process and has wide applications in tableting and capsulation.

Services offered include:

1. 1. Toxicity testing for ingredient combinations.
   
   
2. Ingredient compatibility studies: Stability and interactions between active ingredients.

In addition, Sami Labs Ltd., Sabinsa’s research and manufacturing facilities in India have the capabilities to conduct efficacy tests for health claims, as well as safety studies on various active compounds, herbal extracts and finished formulations:

A partial list is as follows:

Cosmeceutical Claims:

01. Skin Fairness / Luminosity enhancer

• Tyrosinase Enzyme inhibition
• Melanocyte cell culture inhibition studies
  
  
  

02. Anti-wrinkle claim

• In vitro Elastase inhibition
• In vitro Collagenase inhibition
• In vitro Hyaluronidase inhibition
  
  
  

03. Vitiligo support

• Melanocyte proliferation studies
  
  
  

04. Anti- inflammatory / Analgesic

• In vitro Cyclooxygenase inhibition
• In vitro Lipoxygenase inhibition
• In vitro Metalloprotease inhibition
  
  
  

05. Antioxidant activity

• In vitro Lipid Peroxidation inhibition
• DPPH radical scavenging activity
  
  
  

06. Anti-obesity/Weight Management

• In vitro Pancreatic Lipase inhibition
  
  
  

07. Anti-Cancer activity

• Liver Carcinoma cell lines HEP-G2
• Larynx Carcinoma cell line HEP-2
• Melanoma
  
  
  

08. Transmembrane Permeability studies

• Franz diffusion studies
  
  
  

09. D ye color uptake in hair swatches

10.Antibacterial activity against:

• Staphylococcus aureus
• Staphylococcus epidermidis
• Bacillus subtilis
• Streptococcus. mutans
• Escherichia coli
• Candida albicans
  
  
  

11.Anti-acne studies: activity against

• Propionibacterium acnes
  
  
  

12.Anti-Dandruff studies: activity against

• Pityrosporum ovale
  
  
  

13.Pigmentation Enhancing activity (Hair color/ skin tanning)

14.Blood Glucose Management

• Alpa-glucosidase inhibition activity
• Alpha-amylase inhibition activity
  
  
  

Safety Claims (with associate groups)

1. Primary skin irritation
2. Acute oral toxicity
3. Dermal sensitization
4. Acute dermal toxicity
5. Chronic oral toxicity
6. Ocular toxicity
7. Repeat Insult Patch Testing (Human Volunteers)
8. Bacterial Mutagenicity
9. Cytotoxicity
   
   
   

Human efficacy claims

1. Fairness/Luminosity Efficacy Trials:
   The skin melanin index is measured using the Mexameter.
   
   
2. Evaluation of efficacy of under eye preparations:
   Dark circle / puffiness for Under Eye Creams/Formulations
   
   
3. Moisturizing Efficacy:
   The skin moisture content will be measured using the Corneometer.
   
   
4. Skin tone / Age-defying properties :
   The skin roughness will be measured using the Skin Visiometer and the skin elasticity will be measured using the Cutometer.
   
   
5. Anti-wrinkle properties :
   The skin elasticity/wrinkles will be measured using the Cutometer

Chemical Market Reporter, Global Cosmetics Industry, Cosmetics & Toiletries, Perfumery and Flavorist

Functional Foods & Nutraceuticals, Natural Products Insider