Table 1. Comparison of powder properties- Fujicalin® with other DCPA's
Fujicalin has distinct advantages with respect to specific surface area, angle of repose and oil adsorption capacity when compared to other DCPA's.
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Experimental Methods:
Acetaminophen tablets were prepared by direct compression technique with Fujicalin® and three other DCPA's. Micronized acetaminophen (14 µm) was blended with DCPA's and the powder as well as tablet properties were compared with Fujicalin®.
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Table. 2 Formulation summary
Croscarmellose sodium was used as a disintegrant and Magnesium stearate (Mg-St) as lubricant.
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Results:
Fig. 1. Content uniformity of powder blend of micronized acetaminophen with Fujicalin® and other DCPA's
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Blending of micronized acetaminophen powder and DCPA's were carried out for 30 minutes in a 2 Litre V shaped low shear blender at 40 rpm. Samples were chosen from three predefined locations in the blender at 5 minute intervals and checked for content uniformity using spectroscopic assay. Fujicalin® showed easy blending character when compared to other DCPA's. DCPA 2 tends to segregate after 20 minutes of blending. The extended blending was carried out to check the stability of tabletting operations like transfer to hopper prior to tabletting. |
Fig 2. Tablet hardness of acetaminophen tablets directly compressed with Fujicalin® and other DCPA's
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Tabletting was carried out in a rotary tabletting machine (2 HT AP18SS) manufactured by Hata Iron Works, at 400 to 1000 Kgf. Tablet dimensions (Ř8mm x 9mmR); Tablet weight (275 mg). Fujicalin® and DCPA3 showed similar tabletting properties with respect to hardness. DCPA1 showed poor moldability and DCPA2 was not considered for tabletting due to segregation of blends. |
Fig 3. Dissolution profile of directly compressed acetaminophen tablets and DCPA 3
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Dissolution was carried out as per JPC in purified water at 37°C at a paddle speed of 50 rpm. The acetaminophen content was determined spectrophotometrically. More than 85% of the drug was released within 15 minutes of dissolution. DCPA 1 was not tested due to poor hardness of tablets. |
Conclusions:
Among the DCPA's tested, Fujicalin® showed superior powder and tabletting properties after blending with low density micronized acetaminophen. Fujicalin® is spherically granulated, and has high specific surface area when compared to other available DCPA's.
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Summary:
Fujicalin® was the best performer giving higher tablet hardness at low compression forces and improved dissolution profile when compared to other DCPA's.
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Dosage and Safety:
Fujicalin® is manufactured under strict quality control at our FDA-GMP certified facilities. Dibasic calcium phosphate anhydrous is widely used in oral pharmaceutical products and food products. It is generally regarded as relatively nontoxic and nonirritant material.
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Chemical formula : CaHPO4
Chemical Abstract Service (CAS) Number: 7757-93-9
U.S. Patent No. 5,486,365, Jan 1996
U.S. Drug Master File (DMF) filed, Conforms to USP/NF, EP and JP; and listed as GRAS |
