scholarly journals Study on Mechanism for Amorphous Drug Stabilization Using Gelucire 50/13

2009 ◽  
Vol 57 (9) ◽  
pp. 937-942 ◽  
Author(s):  
Shamkant Laxman Shimpi ◽  
Kakasaheb Ramoo Mahadik ◽  
Anant Raghunath Paradkar
Keyword(s):  
Drug Stabilization ◽  
Amorphous Drug

Excipients That Facilitate Amorphous Drug Stabilization

2015 ◽  
pp. 463-495
Author(s):  
Yangjie Wei ◽  
Bhaswati Dattachowdhury ◽  
Kiran K. Vangara ◽  
Niraja Patel ◽  
Kenneth Alexander ◽  
...  
Keyword(s):  
Drug Stabilization ◽  
Amorphous Drug

Amorphous drug stabilization using mesoporous materials

2020 ◽  
pp. 151-166
Author(s):  
Danillo F.M.C. Veloso ◽  
Matthias M. Knopp ◽  
Korbinian Löbmann
Keyword(s):  
Mesoporous Materials ◽  
Drug Stabilization ◽  
Amorphous Drug

Miniaturized screening of polymers for amorphous drug stabilization (SPADS): Rapid assessment of solid dispersion systems

2013 ◽  
Vol 84 (3) ◽  
pp. 583-598 ◽  
Author(s):  
Nicole Wyttenbach ◽  
Christine Janas ◽  
Monira Siam ◽  
Matthias Eckhard Lauer ◽  
Laurence Jacob ◽  
...  
Keyword(s):  
Solid Dispersion ◽  
Rapid Assessment ◽  
Dispersion Systems ◽  
Drug Stabilization ◽  
Amorphous Drug

Comparative Assessment of Miniaturized Screening Approaches for Selection of Polymers for Amorphous Drug Stabilization

2018 ◽  
Vol 107 (3) ◽  
pp. 897-908 ◽  
Author(s):  
Alamelu Banda ◽  
Arushi Manchanda ◽  
Wei Zhang ◽  
Grace May Alba ◽  
Karthik Nagapudi
Keyword(s):  
Comparative Assessment ◽  
Drug Stabilization ◽  
Amorphous Drug ◽  
Selection Of ◽  
Screening Approaches

Amorphous and Crystalline Particulates: Challenges and Perspectives in Drug Delivery

2017 ◽  
Vol 23 (3) ◽  
pp. 350-361 ◽  
Author(s):  
Hisham Al-Obaidi ◽  
Mridul Majumder ◽  
Fiza Bari
Keyword(s):  
Crystal Engineering ◽  
Drug Carrier ◽  
Solid Dispersions ◽  
Chemical Properties ◽  
Pharmaceutical Product ◽  
Water Soluble ◽  
Amorphous Form ◽  
Physico Chemical ◽  
Water Soluble Drugs ◽  
Amorphous Drug

Crystalline and amorphous dispersions have been the focus of academic and industrial research due to their potential role in formulating poorly water-soluble drugs. This review looks at the progress made starting with crystalline carriers in the form of eutectics moving towards more complex crystalline mixtures. It also covers using glassy polymers to maintain the drug as amorphous exhibiting higher energy and entropy. However, the amorphous form tends to recrystallize on storage, which limits the benefits of this approach. Specific interactions between the drug and the polymer may retard this spontaneous conversion of the amorphous drug. Some studies have shown that it is possible to maintain the drug in the amorphous form for extended periods of time. For the drug and the polymer to form a stable mixture they have to be miscible on a molecular basis. Another form of solid dispersions is pharmaceutical co-crystals, for which research has focused on understanding the chemistry, crystal engineering and physico-chemical properties. USFDA has issued a guidance in April 2013 suggesting that the co-crystals as a pharmaceutical product may be a reality; but just not yet! While some of the research is still oriented towards application of these carriers, understanding the mechanism by which drug-carrier miscibility occurs is also covered. Within this context is the use of thermodynamic models such as Flory-Huggins model with some examples of studies used to predict miscibility.

Exploiting Kinetic Solubility Differences for Low Level Detection of Crystallinity in Amorphous Drug Formulations

2020 ◽  
Vol 16 (5) ◽  
pp. 529-538
Author(s):  
Gregory K. Webster ◽  
Cynthia A. Pommerening ◽  
Whitney W. Harman ◽  
Mathew A. Gragg ◽  
Jian-Hwa Han ◽  
...  
Keyword(s):  
Dosage Form ◽  
Amorphous State ◽  
Analytical Techniques ◽  
Drug Level ◽  
Drug Substance ◽  
Phase Iii ◽  
Drug Formulations ◽  
Total Recovery ◽  
Amorphous Drug ◽  
Kinetic Solubility

Background: Enabling formulations have been implemented by the pharmaceutical industry as an effective tool for keeping Active Pharmaceutical Ingredient (API) in an amorphous state. Upon dosing in the amorphous state, many drugs which fail to demonstrate bioactivity due to the limited solubility and bioavailability of their crystalline form become bioavailable. Purpose: The analytical techniques use today for crystallinity detection are challenged by the sensitivity and robustness needed to achieve a 5% quantitation limit in low dose drug products. Our laboratory has developed a novel procedure capable of meeting this sensitivity and selectivity requirement. This is achieved by exploiting the differences in kinetic solubility of the formulated amorphous and free crystalline forms of API currently being used in dosage form platforms. Methods: Representative amorphous drug formulations were prepared and spiked with varying levels of crystalline drug substances to evaluate the selectivity and recovery of the crystalline drug substance from the product formulation. Kinetic solubility testing using a (i) Particle wetting phase, (ii) Particle suspending/erosion phase, (iii) Sampling time point and (iv) A total recovery determination for the drug substance. Results: The method selectively and quantitatively distinguishes crystalline drug substance from amorphous drug substance for samples spiked from 2.5% to 10% of the nominal label concentration of the API in the dosage form matrix. Conclusion: The kinetic solubility approach reported here achieves sensitive crystallinity quantitation for low drug level amorphous drug formulations at levels not yet achieved by complimentary analytical techniques.

Amorphous Drug Nanosuspensions. 3. Particle Dissolution and Crystal Growth

Langmuir ◽  
2007 ◽  
Vol 23 (19) ◽  
pp. 9866-9874 ◽  
Author(s):  
Lennart Lindfors ◽  
Pia Skantze ◽  
Urban Skantze ◽  
Jan Westergren ◽  
Ulf Olsson
Keyword(s):  
Crystal Growth ◽  
Particle Dissolution ◽  
Amorphous Drug

Supersaturating drug delivery systems: The potential of co-amorphous drug formulations

2017 ◽  
Vol 532 (1) ◽  
pp. 1-12 ◽  
Author(s):  
Riikka Laitinen ◽  
Korbinian Löbmann ◽  
Holger Grohganz ◽  
Petra Priemel ◽  
Clare J. Strachan ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Drug Delivery Systems ◽  
Delivery Systems ◽  
Drug Formulations ◽  
Amorphous Drug
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