High-Flow Nasal Cannula Therapy for Exertional Dyspnea in Patients with Cancer: A Pilot Randomized Clinical Trial.

Background: Exertional dyspnea is common in patients with cancer and limits their function. The impact of high-flow nasal cannula on exertional dyspnea in nonhypoxemic patients is unclear. In this double-blind, parallel-group, randomized trial, we assessed the effect of flow rate (high vs.

High-Flow Oxygen and High-Flow Air for Dyspnea in Hospitalized Patients with Cancer: A Pilot Crossover Randomized Clinical Trial.

Background: The effect of high-flow oxygen (HFOx) and high-flow air (HFAir) on dyspnea in nonhypoxemic patients is not known. We assessed the effect of HFOx, HFAir, low-flow oxygen (LFOx), and low-flow air (LFAir) on dyspnea.

Subjects, Materials, And Methods: This double-blind, 4×4 crossover clinical trial enrolled hospitalized patients with cancer who were dyspneic at rest and nonhypoxemic (oxygen saturation >90% on room air).

Mental health interventions in schools in low-income and middle-income countries.

Increasing enrolment rates could place schools in a crucial position to support mental health in low-income and middle-income countries. In this Review, we provide evidence for mental health interventions in schools in accordance with a public mental health approach spanning promotion, prevention, and treatment. We identified a systematic review for mental health promotion, and identified further prevention and treatment studies.

Identification, synthesis and characterization of an unknown process related impurity in eslicarbazepine acetate active pharmaceutical ingredient by LC/ESI-IT/MS, H, C and H-H COSY NMR.

A new impurity was detected during high performance liquid chromatographic (HPLC) analysis of eslicarbazepine acetate active pharmaceutical ingredient. The structure of unknown impurity was postulated based on liquid chromatography mass spectrometry using electrospray ionization and ion trap analyzer (LC/ESI-IT/MS) analysis. Proposed structure of impurity was unambiguously confirmed by synthesis followed by characterization using H, C nuclear magnetic resonance spectrometry (NMR), H-H correlation spectroscopy (COSY) and infrared spectroscopy (IR).

Identification and structural elucidation of two process impurities and stress degradants in darifenacin hydrobromide active pharmaceutical ingredient by LC-ESI/MS(n).

The present study describes the identification and characterization of two process impurities and major stress degradants in darifenacin hydrobromide using high performance liquid chromatography (HPLC) analysis. Forced degradation studies confirmed that the drug substance was stable under acidic, alkaline, aqueous hydrolysis, thermal and photolytic conditions and susceptible only to oxidative degradation. Impurities were identified using liquid chromatography coupled with ion trap mass spectrometry (LC-MS/MS(n)).

4-[3,5-Bis(2-hy-droxy-phen-yl)-1H-1,2,4-triazol-1-yl]benzoic acid dimethyl-formamide monosolvate.

In the mol-ecule of deferasirox dimethyl-formamide solvate, C(21)H(15)N(3)O(4)·C(3)H(7)NO, the central 1,2,4-triazole ring is tilted with respect to the benzoic acid and one of the 2-hy-droxy-phenyl units but coplanar with the other 2-hy-droxy-phenyl group, as indicated by the dihedral angles of 33.69 (9), 72.57 (8) and 5.

Identification, characterization and quantification of a new impurity in deferasirox active pharmaceutical ingredient by LC-ESI-QT/MS/MS.

An unknown impurity was detected in deferasirox drug substance by a newly developed high performance liquid chromatography (HPLC) method. The unknown impurity was identified by liquid chromatography-tandem mass spectrometry using electrospray ionization source and Q-trap mass analyzer (LC-ESI-QT/MS/MS). Based on LC-MS/MS data and knowledge of the synthetic scheme of deferasirox, this impurity was proposed as the regio-isomer of deferasirox.

Paliperidone: 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]eth-yl}-9-hy-droxy-2-methyl-1,6,7,8,9,9a-hexa-hydro-pyrido[1,2-a]pyrimidin-4-one.

The title compound (also known as 9-hy-droxy-risperidone), C(23)H(27)FN(4)O(3), is a heterocyclic compound with manifold pharmacological properties. The hy-droxy group shows disorder over two positions, with site-occupancy factors of 0.856 (2) and 0.

Highly efficient, selective, sensitive and stability indicating RP-HPLC-UV method for the quantitative determination of potential impurities and characterization of four novel impurities in eslicarbazepine acetate active pharmaceutical ingredient by LC/ESI-IT/MS/MS.

A novel, sensitive, selective and stability indicating LC-UV method was developed for the determination of potential impurities of eslicarbazepine acetate. High performance liquid chromatographic investigation of eslicarbazepine acetate laboratory sample revealed the presence of several impurities. Three impurities were characterized rapidly and four impurities were found to be unknown.

Quantification of potential impurities by a stability indicating UV-HPLC method in niacinamide active pharmaceutical ingredient.

A sensitive, stability indicating reverse phase UV-HPLC method has been developed for the quantitative determination of potential impurities of niacinamide active pharmaceutical ingredient. Efficient chromatographic separation was achieved on C18 stationary phase in isocratic mode using simple mobile phase. Forced degradation study confirmed that the newly developed method was specific and selective to the degradation products.

A stability indicating simultaneous dual wavelength UV-HPLC method for the determination of potential impurities in fampridine active pharmaceutical ingredient.

A novel, sensitive, stability indicating simultaneous dual wavelength reverse phase UV-HPLC method has been developed for the quantitative determination of potential impurities of fampridine active pharmaceutical ingredient. Efficient chromatographic separation was achieved on a C18 stationary phase in gradient mode and quantitation by ultraviolet dual wavelength detection. The method was validated according to ICH guidelines with respect to specificity, precision, linearity and accuracy.

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities.

Identification, characterization and quantification of new impurities by LC-ESI/MS/MS and LC-UV methods in rivastigmine tartrate active pharmaceutical ingredient.

Six impurities were detected at trace level in rivastigmine tartrate drug substance by a newly developed high performance liquid chromatography method. Three impurities were characterized rapidly and three impurities were found to be unknown. The unknown impurities were enriched and identified with a combination of semi-preparative HPLC and LC/MS/MS techniques.

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities.

Identification and structural elucidation of an unknown impurity in carbamazepine active pharmaceutical ingredient by liquid chromatography-tandem mass spectrometry and semi-preparative chromatographic isolation.

Two impurities were detected in the HPLC analysis of crude carbamazepine active pharmaceutical ingredient. One of the impurities of the order of 0.5% was found to be unknown and has not been reported previously.

The science of USP 1 and 2 dissolution: present challenges and future relevance.

Since its inception, the dissolution test has come under increasing levels of scrutiny regarding its relevance, especially to the correlation of results to levels of drug in blood. The technique is discussed, limited to solid oral dosage forms, beginning with the scientific origins of the dissolution test, followed by a discussion of the roles of dissolution in product development, consistent batch manufacture (QC release), and stability testing. The ultimate role of dissolution testing, "to have the results correlated to in vivo results or in vivo in vitro correlation," is reviewed.