ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms

Rignall, Andy

doi:10.1002/9781118971147.ch1

Cited by 29 publications

(12 citation statements)

References 22 publications

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“…The stability of the lyophilized voriconazole LPH NPs was determined employing humidity chambers (M/s Newtronic Lifecare Equipment, Mumbai, India). The samples were stored in glass vials for a period of 90 days at different temperature and humidity conditions, i.e., 5 °C ± 3 °C, 25 °C ± 2 °C/60 ± 5% RH; 40 °C ± 2 °C/75 ± 5% RH [ 54 ]. The lyophilized samples were reconstituted in sterile water at 0, 30 and 90 days, bath-sonicated for 30 min, and were analysed for possible change in PS, PDI and EE.…”

Section: Methodsmentioning

confidence: 99%

Nebulised surface-active hybrid nanoparticles of voriconazole for pulmonary Aspergillosis demonstrate clathrin-mediated cellular uptake, improved antifungal efficacy and lung retention

et al. 2021

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Background Incidence of pulmonary aspergillosis is rising worldwide, owing to an increased population of immunocompromised patients. Notable potential of the pulmonary route has been witnessed in antifungal delivery due to distinct advantages of direct lung targeting and first-pass evasion. The current research reports biomimetic surface-active lipid-polymer hybrid (LPH) nanoparticles (NPs) of voriconazole, employing lung-specific lipid, i.e., dipalmitoylphosphatidylcholine and natural biodegradable polymer, i.e., chitosan, to augment its pulmonary deposition and retention, following nebulization. Results The developed nanosystem exhibited a particle size in the range of 228–255 nm and drug entrapment of 45–54.8%. Nebulized microdroplet characterization of NPs dispersion revealed a mean diameter of ≤ 5 μm, corroborating its deep lung deposition potential as determined by next-generation impactor studies. Biophysical interaction of LPH NPs with lipid-monolayers indicated their surface-active potential and ease of intercalation into the pulmonary surfactant membrane at the air-lung interface. Cellular viability and uptake studies demonstrated their cytocompatibility and time-and concentration-dependent uptake in lung-epithelial A549 and Calu-3 cells with clathrin-mediated internalization. Transepithelial electrical resistance experiments established their ability to penetrate tight airway Calu-3 monolayers. Antifungal studies on laboratory strains and clinical isolates depicted their superior efficacy against Aspergillus species. Pharmacokinetic studies revealed nearly 5-, 4- and threefolds enhancement in lung AUC, Tmax, and MRT values, construing significant drug access and retention in lungs. Conclusions Nebulized LPH NPs were observed as a promising solution to provide effective and safe therapy for the management of pulmonary aspergillosis infection with improved patient compliance and avoidance of systemic side-effects.

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Section: Methodsmentioning

confidence: 99%

Nebulised surface-active hybrid nanoparticles of voriconazole for pulmonary Aspergillosis demonstrate clathrin-mediated cellular uptake, improved antifungal efficacy and lung retention

et al. 2021

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“…For stability testing, performed after storage at 20 ± 5°C, the following parameters were determined: norepinephrine concentration, pH, clarity, color of solution, subvisible particles, and sterility. The time intervals were according to ICH guidelines ( 16 ).…”

Section: Methodsmentioning

confidence: 99%

“…Further validation was performed to demonstrate linearity, accuracy, and precision of the method according to ICH guidelines ( 16 ). For the linearity, the calibration curve was prepared using the peak areas obtained from the chromatograms of the injections with a known concentration of norepinephrine in a range of 25.0 to 75.0 mg/L.…”

Section: Methodsmentioning

confidence: 99%

Prefilled Cyclic Olefin Sterilized Syringes of Norepinephrine Injection Solution Do Not Need to Be Stabilized by Antioxidants

et al. 2020

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Norepinephrine is a potent α-sympathomimetic drug which plays an important role in the acute treatment of hypotension and shock. Commercially available norepinephrine solutions contain sodium metabisulfite (Na2S2O5) as an antioxidant. However, prefilled cyclic olefin polymer syringes are not compatible with sodium metabisulfite. The aim of this study was to develop a new formulation of 0.1-mg/mL norepinephrine solution without sodium metabisulfite which is chemically stable and sterile and can be stored in prefilled polymer syringes. Formulation studies were performed with 0.1-mg/mL norepinephrine solution with 0, 0.05, or 0.1% ascorbic acid added as antioxidant. The syringes were filled under nitrogen gassing, stored at 20 ± 5°C, and protected from daylight. Based on the formulation test results, the final formulation was defined and stability testing at 20 ± 5°C was performed measuring norepinephrine concentration, pH, clarity, color of the solution, subvisible particles, and sterility at time intervals up to 12 months. The norepinephrine concentrations at t = 22 weeks were 100.4%, 95.4%, and 92.2% for the formulations with no ascorbic acid and with 0.05% and 0.10% ascorbic acid, respectively. Three batches for the stability study were produced containing norepinephrine, sodium edetate, sodium chloride, and water for injections filled under nitrogen gassing and stored at 20 ± 5°C. Norepinephrine concentrations were respectively 98.8%, 98.6%, and 99.3% for batches 1, 2, and 3 at t = 12 months. It can be concluded that norepinephrine (0.1 mg/mL) solution without metabisulfite is stable for at least 12 months at room temperature when protected from daylight.

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“…According to the International Conference on Harmonization (ICH) Q2 (R1) confirmation of the applicability of this approach was validated. 16 Vitamins have been classified into water-soluble and fat-soluble vitamins, both of which can be easily measured utilizing reverse phase High-Performance Liquid Chromatography. 17 For quantification from germinated chickpeas, water-soluble vitamins such as B1, B2, B3, and B6 can be identified.…”

Section: Introductionmentioning

confidence: 99%

High Performance Liquid Chromatographic Method for the Analysis of Pyridoxine Hydrochloride in Liquid Dosage Form

2021

TJNPR

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ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms

Cited by 29 publications

References 22 publications

Nebulised surface-active hybrid nanoparticles of voriconazole for pulmonary Aspergillosis demonstrate clathrin-mediated cellular uptake, improved antifungal efficacy and lung retention

Nebulised surface-active hybrid nanoparticles of voriconazole for pulmonary Aspergillosis demonstrate clathrin-mediated cellular uptake, improved antifungal efficacy and lung retention

Prefilled Cyclic Olefin Sterilized Syringes of Norepinephrine Injection Solution Do Not Need to Be Stabilized by Antioxidants

High Performance Liquid Chromatographic Method for the Analysis of Pyridoxine Hydrochloride in Liquid Dosage Form

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