Polymeric Amorphous Solid Dispersions: A Review of Amorphization, Crystallization, Stabilization, Solid-State Characterization, and Aqueous Solubilization of Biopharmaceutical Classification System Class II Drugs

Amorphous solid dispersions: An update for preparation, characterization, mechanism on bioavailability, stability, regulatory considerations and marketed products

Solid-State Nuclear Magnetic Resonance Spectroscopy-Pharmaceutical Applications

Solid-state NMR (SSNMR) can provide detailed structural information about amorphous solid dispersions of pharmaceutical small molecules. In this study, the ability of SSNMR experiments based on dipolar correlation, spin diffusion, and relaxation measurements to characterize the structure of solid dispersions is explored. Observation of spin diffusion effects using the 2D 1H−13C cross-polarization heteronuclear correlation (CP-HETCOR) experiment is shown to be a useful probe of association between the amorphous drug and polymer that is capable of directly proving glass solution formation. Dispersions of acetaminophen and indomethacin in different polymers are examined using this approach, as well as 1H double-quantum correlation experiments to probe additional structural features. 1H−19F CP-HETCOR serves a similar role for fluorinated drug molecules such as diflunisal in dispersions, providing a rapid means to prove the formation of a glass solution. Phase separation is detected using 13C, 19F, and 23Na-de...

Analysis of Amorphous Solid Dispersions Using 2D Solid-State NMR and 1H T1 Relaxation Measurements

Purpose
The stabilization mechanism of a supersaturated solution of mefenamic acid (MFA) from a solid dispersion with EUDRAGIT® EPO (EPO) was investigated.

/pdf/stabilization-of-a-supersaturated-solution-of-mefenamic-acid-1ex5qs2gib.pdf

Stabilization of a supersaturated solution of mefenamic acid from a solid dispersion with EUDRAGIT(®) EPO

Characterization of clarithromycin polymorph was performed by solid-state cross polarization and magic angle spinning (CP/MAS) 13C-NMR spectroscopy. Two polymorphs, form II and form I, of clarithromycins indicated characteristic resonances of C1 carbonyl carbon at 176.2 and 175.2 ppm, respectively. Since each peak of C1 carbon was well separated in the spectrum of the two polymorphs, we performed quantitative analysis of the polymorphic fraction from the peak area of these peaks. The peak area of form I was found to linearly increase with an increase of its content, with a correlation coefficient of above 0.99. Solid-state NMR was found to be a useful technique to determine the characteristics of the polymorphic forms.

https://cpb.pharm.or.jp/cpb/200208/c08_1128.pdf

Characterization and quantitation of clarithromycin polymorphs by powder X-ray diffractometry and solid-state NMR spectroscopy.

An object of the present invention is to provide a method for producing selectively a powder particle consisting of the α-form crystal of D-mannitol, using the spray-drying method. It is a method for selective production of powder particles consisting of the α-form crystal of D-mannitol, wherein a D-mannitol solution containing a water-soluble polymer is spray-dried.

Selective production method for D-mannitol α-form crystal using spray-drying method

An object of the present invention is to provide a pharmaceutical composition having abuse deterrent properties and thereby prevent the abuse of a pharmacologically active component by an abuser (abuse through snorting, abuse through injection, or abuse through snorting or injection of a temporarily extracted drug). The present invention provides a pharmaceutical composition having abuse deterrent properties that possesses both a physical barrier and a chemical barrier to being abused by an abuser, a method for producing the same and a method for using the same.

Pharmaceutical composition having abuse deterrent properties

[Problem] To prevent abuse of a pharmacologically active ingredient by an abuser by providing a pharmaceutical composition having an abuse-prevention function (abuse by nasal inhalation, abuse by injection, and abuse by extracting a drug and inhaling nasally or injecting). [Solution] To provide: a pharmaceutical composition having an abuse-prevention function having both a physical barrier and a chemical barrier when an abuser tries to abuse the pharmaceutical composition; a method for producing same; and a method for using same.

Pharmaceutical composition provided with abuse-prevention function

Disclosed is a pharmaceutical composition comprising a fructose 1,6-bisphosphatase (FBPase) inhibitor, which has excellent drug dissolution property, drug content uniformity, mass uniformity, hardness and wear resistance. Also disclosed is a solid preparation comprising the step of formulating a composition comprising a fructose 1,6-bisphosphatase inhibitor into a preparation by a dry process.

Preparation produced by dry process

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