Review of industrially recognized polymers and manufacturing processes for amorphous solid dispersion based formulations

Saha, Sumit Kumar; Joshi, Amita; Singh, Rajiv; Dubey, Kiran

doi:10.1080/10837450.2023.2233595

Cited by 3 publications

(1 citation statement)

References 175 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The emergence of pharmaceutical industrial initiatives appears to be even more innovative. If the numbers of appropriate polymers exposed to manufacturing technologies are limited, ongoing work is expected to develop new ASD drug formulations [98].…”

Section: Discussionmentioning

confidence: 99%

Autism Spectrum Disorder: Brain Areas Involved, Neurobiological Mechanisms, Diagnoses and Therapies

Lamanna,

Meldolesi

2024

IJMS

View full text Add to dashboard Cite

Autism spectrum disorder (ASD), affecting over 2% of the pre-school children population, includes an important fraction of the conditions accounting for the heterogeneity of autism. The disease was discovered 75 years ago, and the present review, based on critical evaluations of the recognized ASD studies from the beginning of 1990, has been further developed by the comparative analyses of the research and clinical reports, which have grown progressively in recent years up to late 2023. The tools necessary for the identification of the ASD disease and its related clinical pathologies are genetic and epigenetic mutations affected by the specific interaction with transcription factors and chromatin remodeling processes occurring within specific complexes of brain neurons. Most often, the ensuing effects induce the inhibition/excitation of synaptic structures sustained primarily, at dendritic fibers, by alterations of flat and spine response sites. These effects are relevant because synapses, established by specific interactions of neurons with glial cells, operate as early and key targets of ASD. The pathology of children is often suspected by parents and communities and then confirmed by ensuing experiences. The final diagnoses of children and mature patients are then completed by the combination of neuropsychological (cognitive) tests and electro-/magneto-encephalography studies developed in specialized centers. ASD comorbidities, induced by processes such as anxieties, depressions, hyperactivities, and sleep defects, interact with and reinforce other brain diseases, especially schizophrenia. Advanced therapies, prescribed to children and adult patients for the control of ASD symptoms and disease, are based on the combination of well-known brain drugs with classical tools of neurologic and psychiatric practice. Overall, this review reports and discusses the advanced knowledge about the biological and medical properties of ASD.

show abstract

Section: Discussionmentioning

confidence: 99%

Autism Spectrum Disorder: Brain Areas Involved, Neurobiological Mechanisms, Diagnoses and Therapies

Lamanna,

Meldolesi

2024

IJMS

View full text Add to dashboard Cite

show abstract

Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023

Moseson,

Tran,

Karunakaran

et al. 2024

International Journal of Pharmaceutics: X

View full text Add to dashboard Cite

Amorphous Solid Dispersions: Implication of Method of Preparation and Physicochemical Properties of API and Excipients

Kushwah,

Succhielli,

Saraf

et al. 2024

Pharmaceutics

View full text Add to dashboard Cite

The present study investigated the effect of different polymers and manufacturing methods (hot melt extrusion, HME, and spray drying, SD) on the solid state, stability and pharmaceutical performance of amorphous solid dispersions. In the present manuscript, a combination of different binary amorphous solid dispersions containing 20% and 30% of drug loadings were prepared using SD and HME. The developed solid-state properties of the dispersions were evaluated using small- and wide-angle X-ray scattering (WAXS) and modulated differential scanning calorimetry (mDSC). The molecular interaction between the active pharmaceutical ingredients (APIs) and polymers were investigated via infrared (IR) and Raman spectroscopy. The in vitro release profile of the solid dispersions was also evaluated to compare the rate and extend of drug dissolution as a function of method of preparation. Thereafter, the effect of accelerated stability conditions on the physicochemical properties of the solid dispersions were also evaluated. The results demonstrated higher stability of Soluplus® (SOL) polymer-based solid dispersions as compared to hydroxypropyl methylcellulose (HPMC)-based solid dispersions. Moreover, the stability of the solid dispersions was found to be higher in the case of API having high glass transition temperature (Tg) and demonstrated higher interaction with the polymeric groups. Interestingly, the stability of the melt-extruded dispersions was found to be slightly higher as compared to the SD formulations. However, the down-processing of melt-extruded strands plays critical role in inducing the API crystal nuclei formation. In summary, the findings strongly indicate that the particulate properties significantly influence the performance of the product.

show abstract

Review of industrially recognized polymers and manufacturing processes for amorphous solid dispersion based formulations

Cited by 3 publications

References 175 publications

Autism Spectrum Disorder: Brain Areas Involved, Neurobiological Mechanisms, Diagnoses and Therapies

Autism Spectrum Disorder: Brain Areas Involved, Neurobiological Mechanisms, Diagnoses and Therapies

Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023

Amorphous Solid Dispersions: Implication of Method of Preparation and Physicochemical Properties of API and Excipients

Contact Info

Product

Resources

About