For total versatility in design and development of tablet formulation a quality enhancing cost effective diluent for solid dosage forms.
CALPAX®
AN IDEAL DILUENT CALPAX IS:
1. Nontoxic, Chemically & Physiologically inert.
2. Physically & Chemically stable both by itself and in combination with the drug.
3. Free of unacceptable microbes & does not support mould growth.
4. Colour compatible and maintains the uniformity of shades.
5. Has no deleterious effect on the bioavailability of active drug.
Important Links
Product Specification:
Physical Analysis
Test |
Limit |
Physical form |
A fine, odourless, tasteless, amorphous powder |
Colour |
White |
Effect of heat |
Looses 1½H2O at 128ºC & 2H2O at 163ºC |
Chemical Analysis
Identification Test – USP-NF |
Passes |
Loss on Drying – USP-NF |
Passes |
Iron – USP-NF |
Passes |
Heavy Metals – USP-NF |
Passes |
Assay – USP-NF |
98% - 101% |
Foreign Particles – In house |
Passes |
Chloride – In house |
Passes |
pH – In house |
Neutral to litmus |
Microbiological Analysis
Total viable Aerobic Count |
NMT 10 / g |
Fungi |
NMT 10 / g |
Total Coliform, Salmonella, Staphylococcus aureus, |
Absent in 10 g |
Comparative Practical Observation
| Quality | Calpax | Lactose | DCP |
| Effect on D.T. | Best | Good | Better |
| Surface Finish | Best | Best | Poor |
| Friability | Low | Lowest | High |
| Wear-Tear of Die-Sets | Low | Minimum | High |
| Colour Distribution | Best | Good | Poor |
| Setting effects during shelf life |
Least | Highest | High |
| Effect on appearance during shelf life |
No change | May turn brownish (Haillard Reaction) |
Turns off-white |
| Probability of microbial contamination | Minimum | Fair | Maximum |
| Acceptability to diabetic patient | Most | Minimum | Fair |
| Cost | Least | Most | fair |
Products Grades Available:
Calpax® Powder: A fine powder for wet granulation. It can be used upto 75% or three-fourth of the total diluent portion in combination with starch maintaining disintegration time to the minimum.
Calpax® - D.C.: (Direct compressible granules of desired size) - whenever direct compression is feasible, readymade granules of the diluents are required. Calpax-D.C. is ideal form for immediate use. When size/weight of a tablet is needed to be increased, Calpax dummy granules are very handy. Calpax-D.C. does not require any other excipient except disintegrating and lubricating agents.
Calpax® - C (Capsule grade free flow granular powder)-Capsule filled on semi-automatic or automatic machines need flowability of the bulk material. Calpax-C serves the purpose. Calpax-C increases the flow of the material thereby filling is faster & uniform resulting in enhanced production.
Calpax® - ST: This is especially introduced for Steroids like Dexa / Beta - methasone and Prednisolone etc.
Calpax® - VET: This is a fine powder which is used in FEED - FORMULATIONS through wet process or as fillers in powders. It is widely used as Calcium Suppliment.
Direct Compression
For direct compression, Calpax DC (Directly Compressible), grade of CALPAX is used.
In this process, active ingredients and excipients (D.C. form) are blended and compressed directly. It is the most widely accepted, less elaborate, most economical way of production.
Advantages of Direct Compression are as under:
Conclusion:
Calpax is diluent of the right choice for solid dosage forms. It offers total versatility in design and development of tablet formulation and affords protection from mould & microbes.