DESIGNING A PLATFORM TECHNOLOGY FOR AGE APPROPRIATE PEDIATRIC DOSAGE FORM

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 14-23
Author(s):  
D. M. More ◽  
◽  
P. D. Chaudhari ◽  
S. D. More
Keyword(s):  
Dosage Form ◽  
Bitter Taste ◽  
Oral Dosage ◽  
Taste Masking ◽  
Oral Dosage Form ◽  
Solid Oral Dosage Form ◽  
Platform Technology ◽  
Age Appropriate ◽  
Eudragit Epo ◽  
Hot Melt

Present work was aimed to develop a platform technology for pediatric dosage form which masks the bitter taste of a drug and to prepare flexible solid oral dosage form using hot melt extrusion (HME). Eudragit EPO, a cationic co-polymer insoluble in pH above 5, was used as a taste masking polymer to restrict the drug release in saliva. Soluplus, a graft co-polymer freely soluble in water was used as solubility enhancer. Test formulation released less than 10 % drug Tenofovir Disoproxil Fumarate (TDF) in pH 6.8 compared to 89% of marketed formulation simulated to limited release of drug in the saliva and thus avoiding the bitterness. DSC and XRD tests confirmed the existence of molecularly dispersed drug. FTIR confirmed the presence of unchanged functional groups of drug in its tablet form after HME processing. Proposed platform technology successfully masked the bitter taste in the ratio of D:P 1:2 and overcame this challenge of oral dosage form.

scholarly journals TASTE MASKING BY HOT MELT EXTRUSION WITHOUT LOSS OF BIOAVAILABILITY FOR PEDIATRICS

2019 ◽  
pp. 7-13
Author(s):  
Dhananjay M. ◽  
Pravin C. ◽  
Smita M.
Keyword(s):  
Fourier Transform ◽  
Infrared Spectroscopy ◽  
Drug Release ◽  
Fourier Transform Infrared Spectroscopy ◽  
Dosage Form ◽  
Bitter Taste ◽  
Taste Masking ◽  
Platform Technology ◽  
Eudragit Epo ◽  
Hot Melt

Objective: The aim of present work was to develop a platform technology for the pediatric dosage form to mask the bitter taste of Furosemide (FUR) and prepare a flexible solid oral dosage form. Methods: Excipient compatibility study was carried out by using Fourier-transform infrared spectroscopy (FTIR). Taste masking was done by hot melt extrusion (HME) technology. Eudragit EPO and Soluplus were used as a taste masking and solubilizing polymers respectively. The prepared solid dispersion and tablets were evaluated for their physicochemical parameters such as hardness, friability, disintegration, in vitro drug release. Results: Experimental data revealed that physical integrity, brittleness of granules, conversion of a drug in amorphous form was improved by combining Eudragit EPO with Soluplus. Plasticizer helped to complete HME at 80 °C. Less than 10% drug release in pH 6.8 medium revealed that release would be extremely limited in the saliva and thus avoiding bitterness. Animal study data revealed that bioavailability has been increased by 30%. Differential scanning calorimetry (DSC) and x-ray diffraction (XRD) tests confirmed the existence of molecularly dispersed drug. Fourier-transform infrared spectroscopy (FTIR) confirmed the unchanged functional groups of FUR after HME processing. Conclusion: Proposed platform technology masked the bitter taste and enhanced the bioavailability of FUR in D: P ratio of 1:2.

Mechanistic Studies of the N-formylation of Edivoxetine, a Secondary Amine-Containing Drug, in a Solid Oral Dosage Form

2017 ◽  
Vol 106 (5) ◽  
pp. 1218-1238 ◽  
Author(s):  
Cherokee S. Hoaglund Hyzer ◽  
Michele L. Williamson ◽  
Patrick J. Jansen ◽  
Michael E. Kopach ◽  
R. Brian Scherer ◽  
...  
Keyword(s):  
Secondary Amine ◽  
Dosage Form ◽  
Oral Dosage ◽  
Mechanistic Studies ◽  
Oral Dosage Form ◽  
Solid Oral Dosage Form

Technical Note: Determination of Cholecalciferol (Vitamin D3) in Standard Reference Material 3532 Calcium-Containing Solid Oral Dosage Form

2017 ◽  
Vol 100 (5) ◽  
pp. 1304-1307 ◽  
Author(s):  
Carolyn Q Burdette
Keyword(s):  
Vitamin D3 ◽  
Dosage Form ◽  
Well Being ◽  
Technical Note ◽  
National Institutes Of Health ◽  
Oral Dosage ◽  
Oral Dosage Form ◽  
Solid Oral Dosage Form ◽  
Immune Health

Abstract Vitamin D is an important nutrient for many areas of human health and well-being, including improved bone strength, muscle movement, cognitive function, and immune health. The National Institute of Standards and Technology, in collaboration with the National Institutes of Health Office of Dietary Supplements, has developed SRM 3532 Calcium-Containing Solid Oral Dosage Form to help address the analytical challenges seen by the dietary supplement communities for the determination of vitamin D3 (cholecalciferol) and elements. Described here is the process to assess the homogeneity and stability of the material, as well as the value assignment of the vitamin D3 levels.

scholarly journals An evaluation of the adhesion of solid oral dosage form coatings to the oesophagus

2015 ◽  
Vol 496 (2) ◽  
pp. 299-303 ◽  
Author(s):  
John D. Smart ◽  
Sian Dunkley ◽  
John Tsibouklis ◽  
Simon Young
Keyword(s):  
Dosage Form ◽  
Oral Dosage ◽  
Oral Dosage Form ◽  
Solid Oral Dosage Form
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