Robustness Considerations and Effects of Moisture Variations on near Infrared Method Performance for Solid Dosage Form Assay

2014 ◽  
Vol 22 (3) ◽  
pp. 179-188 ◽  
Author(s):  
Benoît Igne ◽  
Md. Nayeem Hossain ◽  
James K. Drennen ◽  
Carl A. Anderson
Keyword(s):  
Dosage Form ◽  
Near Infrared ◽  
Method Performance ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Infrared Method

Application of Near-Infrared Spectroscopy in the Pharmaceutical Solid Dosage Form

1999 ◽  
Vol 25 (12) ◽  
pp. 1267-1270 ◽  
Author(s):  
Jian-Hwa Guo ◽  
G. W. Skinner ◽  
W. W. Harcum ◽  
J. P. Malone ◽  
L. G. Weyer
Keyword(s):  
Infrared Spectroscopy ◽  
Near Infrared Spectroscopy ◽  
Dosage Form ◽  
Near Infrared ◽  
Solid Dosage Form ◽  
Solid Dosage

scholarly journals Evaluation of Tropaeolin 000-1 as a Colorimetric Reagent for Assay of Duloxetine and Escitalopram in Solid Dosage Form

2016 ◽  
Vol 15 (3) ◽  
pp. 613
Author(s):  
Mani Ganesh ◽  
Abidov Sh Aziz ◽  
Mei Mei Peng ◽  
Ramaswamy Ravikumar ◽  
Kalaimani Sakthimanigandan ◽  
...  
Keyword(s):  
Dosage Form ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Colorimetric Reagent

scholarly journals Comparison of UV-spectrophotometric and RP-HPLC methods for estimation of deflazacort in solid dosage form

2020 ◽  
Author(s):  
Puranik Manisha ◽  
Shambharkar Samta ◽  
Nimbalkar Shantanu ◽  
Mahapatra Debarshi Kar
Keyword(s):  
Dosage Form ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Rp Hplc

scholarly journals Interaction between Polyethylene Films and BromhexineHCl in Solid Dosage Form. III. Prevention of Drug Sorption by Improving Manufacturing Processes.

1991 ◽  
Vol 39 (5) ◽  
pp. 1287-1291 ◽  
Author(s):  
Takuya KUKITA ◽  
Akemi YAMAGUCHI ◽  
Akihiko OKAMOTO ◽  
Masami NEMOTO ◽  
Hiroshi YAMAGUCHI ◽  
...  
Keyword(s):  
Dosage Form ◽  
Manufacturing Processes ◽  
Polyethylene Films ◽  
Solid Dosage Form ◽  
Solid Dosage

In-Vitro Functionality of Clozapine Biphasic Release Minitablet Using Advanced Statistical Tools

2021 ◽  
Vol 11 ◽  
Author(s):  
Hardik Rana ◽  
Rushikesh Chaudhari ◽  
Vaishali Thakkar ◽  
Tejal Gandhi
Keyword(s):  
Drug Release ◽  
Sustained Release ◽  
Ethyl Cellulose ◽  
Dosage Form ◽  
Immediate Release ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Precipitation Inhibitor

Background: The better control of the drug release with immediate effect is the major concern to achieve better therapeutic action and patient compliance. The failure of the solid dispersion complex during storage as well as in-vivo is another concern for the oral solid dosage form. Objective: The prime objective of the present study was to optimize the biphasic minitablet incorporating quality by design approach using the combination of waxy erodible and water-impermeable excipients. Exploration of Soluplus as a precipitation inhibitor and Dexolve as a solubility enhancer in oral solid dosage form was the secondary objective. Methods: The drug-Excipient compatibility study was assessed by FTIR. Clozapine was chosen as a model drug that has poor aqueous solubility. The complex was formulated using B-cyclodextrin or HP B-CD or Dexolve by kneading method. The screening of solubility enhancers and their amount were performed based on phase solubility study. The precipitation inhibitor was screened as per the parachute effect study. Immediate release minitablets were formulated using a direct compression method using different disintegrating agents. The IR minitablets were evaluated for different evaluation parameters. The sustained release minitablets was formulated by hot-melt granulation technique incorporating the Precirol ATO 5 as a waxy excipient and ethyl cellulose as water impermeable excipient. The SR minitablet was optimized using a central composite design. The amount of Precirol ATO 5 and ethyl cellulose were chosen as independent variables and % drug release at 1, 6, and 10 h was selected as responses. The designed batches were evaluated for different pre and post compressional parameters. The IR and SR minitablets were filled in a capsule as per dose requirement and evaluated for in-vitro drug release. The in-vivo plasma concentration was predicted using the Back calculation of the Wagner – Nelson approach. Results: Drug – Excipient study revealed that no significant interaction was observed. Dexolve was screened as a solubility enhancer for the improvement of the solubility of clozapine. The Soluplus was chosen as a precipitation inhibitor from the parachute effect study. The immediate-release tablet was formulated using Prosolv EASYtab SP yield less disintegration time with better flowability. The sustained release mini-tablet was formulated using Precirol ATO 5 and ethyl cellulose. Two-dimensional and three-dimensional plots were revealed the significant effect of the amount of Precirol ATO 5 and ethyl cellulose. The overlay plot locates the optimized region. The in-vitro drug release study revealed the desired drug release of the final combined formulation. The in-vivo plasma concentration-time confirms the drug release up to 12h. Conclusion: The biphasic mini-tablets were formulated successfully for better control of drug release leads to high patient compliance. The use of soluplus as a precipitation inhibitor is explored in the oral solid dosage form for a poorly aqueous drug. Prosolv EASYtab SP was incorporated in the formulation as super disintegrant. The amount of Precirol ATO 5 and ethyl cellulose had a significant effect on drug release in sustained-release minitablet. The approach can be useful in the industry.

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