scholarly journals SPLIT-HALF TABLETS: A COMPLETE REVIEW FOR ANALYTICAL TESTING

2019 ◽  
pp. 27-38
Author(s):  
LAKSHMI NARASIMHA RAO KATAKAM
Keyword(s):  
Dosage Form ◽  
Drug Product ◽  
Analytical Techniques ◽  
Quality Attributes ◽  
Oral Dosage ◽  
Analytical Evaluation ◽  
Formulation Development ◽  
Analytical Methodology ◽  
Acceptance Criterion ◽  
Solid Oral Dosage Form

A solid oral dosage form (as a tablet) which is an immediate or extended-release dosage form which necessitates the scoring bisect of the tablet. This review discusses the quality attributes and interpretations for the split studies of the various tablet formulations using the analytical techniques. Each method of analysis for the evaluation of split-half tablets in terms of its critical quality attributes discusses in detail explanation of analytical methodology and challenges in formulation development. The results for quantitative analytical evaluation in terms of finished product/stability testing and release of the split-half drug product against the acceptance criterion and also discusses the flowchart guidance for the investigation of out of specification results. The present article provides an insight into the complete analytical evaluation of split-half drug product testing according to the requirements of tablet scoring as per US food and drug administration.

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.

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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