Formulation and manufacture of pharmaceuticals by fluidized-bed impregnation of active pharmaceutical ingredients onto porous carriers

AIChE Journal ◽  
2013 ◽  
Vol 59 (12) ◽  
pp. 4538-4552 ◽  
Author(s):  
Plamen I. Grigorov ◽  
Benjamin J. Glasser ◽  
Fernando J. Muzzio
Keyword(s):  
Fluidized Bed ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Porous Carriers

scholarly journals Variation in Particle Shape of Active Pharmaceutical Ingredients Prepared by Fluidized-bed Jet-milling

2005 ◽  
Vol 125 (12) ◽  
pp. 951-957 ◽  
Author(s):  
Tadashi FUKUNAKA ◽  
Kohta SAWAGUCHI ◽  
Boris GOLMAN ◽  
Kunio SHINOHARA
Keyword(s):  
Fluidized Bed ◽  
Particle Shape ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Jet Milling

scholarly journals Substantiation of technology for obtaining capsules of a multi-component drug with neurotropic action

2021 ◽  
pp. 10-16
Author(s):  
Maksym Almakaiev ◽  
Larysa Sidenko
Keyword(s):  
Fluidized Bed ◽  
Disodium Salt ◽  
Wet Granulation ◽  
Thioctic Acid ◽  
Active Pharmaceutical Ingredients ◽  
Pyridoxine Hydrochloride ◽  
Acceptance Criteria ◽  
Average Mass ◽  
Pharmaceutical Ingredients ◽  
Mixing Method

The aim of the work. Theoretical and experimental substantiation of a rational technology for obtaining a preparation in the form of capsules based on uridine-5-monophosphate of disodium salt, cytidine-5-monophosphate of disodium salt, vitamin B6, thioctic acid and magnesium lactate dihydrate, determination of process parameters that can affect critical quality characteristics active pharmaceutical ingredients in the product and establishing acceptance criteria for each critical process parameter to be used in batch production and process control. Materials and methods. Objects of the research: masses for encapsulation, granulates and the finished product - capsules with the conventional name “Neuronucleos”. To obtain capsules, active pharmaceutical ingredients (API) were used: uridine-5-monophosphate disodium salt and cytidine-5-monophosphate disodium salt (Shanghai Oripharm Co. Ltd., China), thioctic acid (Shanghai Modern Pharmaceutical Co., Ltd..”, China), pyridoxine hydrochloride (“DSM Nutritional Products GmbH”, Germany), magnesium lactate (“Moes Cantabra S.L.”, Spain). The quality indicators were studied: description, average mass of content and uniformity of mass, uniformity of dosage units, dissolution, accompanying impurities, quantitative content of API. Methods of liquid chromatography and complexometric titration were used. Results. It has been established that the use of the direct mixing method does not allow obtaining a mass for encapsulation corresponding to the indicator "Bulk density". The use of the wet granulation method in a fluidized bed has been substantiated. It has been shown that it is difficult to perform granulation in a fluidized bed of an API mixture containing thioctic acid. It has been established that it is rational to obtain a mass for encapsulation in two stages: obtaining a granulate from magnesium lactate dihydrate and pyridoxine hydrochloride with a moisturizer solution (sorbitol + uridine-5-monophosphate disodium salt + cytidine-5-monophosphate disodium salt) and then obtaining a mass for encapsulation from granulate, thioctic acid, anhydrous colloidal silicon dioxide and magnesium stearate by the direct mixing method. Conclusions. On the basis of the performed technological research and analysis of the quality of the obtained capsules, a method for obtaining a capsule mass using the method of wet granulation in a fluidized bed was chosen. The granulation mode was substantiated and the optimal parameters for obtaining a high-quality product were selected, the acceptance criteria for each critical parameter of the technological process were established

Reversed-Phase High Performance Liquid Chromatographic Analysis of Three First Line Anti-Tuberculosis Drugs

2019 ◽  
Vol 69 (12) ◽  
pp. 3590-3592
Author(s):  
Nela Bibire ◽  
Romeo Iulian Olariu ◽  
Luminita Agoroaei ◽  
Madalina Vieriu ◽  
Alina Diana Panainte ◽  
...  
Keyword(s):  
High Performance ◽  
Biological Fluids ◽  
Gradient Elution ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Assay Method ◽  
Active Pharmaceutical Ingredients ◽  
First Line ◽  
Pharmaceutical Ingredients ◽  
Liquid Chromatographic

Active pharmaceutical ingredients such as isoniazid, pyrazinamide and rifampicin are among the most important first-line anti-tuberculosis drugs. A simple, rapid and sensitive reversed phase-high performance liquid chromatographic assay method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin has been developed. Separation of the interest compounds was achieved in a 10 min chromatographic run in gradient elution mode on a Zorbax SB-C18 stainless steel column (150 � 4 mm, 5 mm) using a guard column containing the same stationary phase. The gradient elution was carried out with a mobile phase of 10% CH3CN aqueous solution for channel A and 50% CH3CN in pH = 6.8 phosphate buffer (20 mM), to which 1.5 mL triethylamine were added for channel B. Quantification of the analyzed substances was carried out spectrophotometrically at 269 nm. Detection limits of 0.48 mg/L for isoniazid, 0.52 mg/L for pyrazinamide and 0.48 mg/L for rifampicin were established for the developed assay method. The present work showed that the proposed analysis method was advantageous for simple and rapid analysis of the active pharmaceutical ingredients in pharmaceuticals and biological fluids.

scholarly journals Numaswitch: an efficient high-titer expression platform to produce peptides and small proteins

AMB Express ◽  
2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Bach-Ngan Nguyen ◽  
Florian Tieves ◽  
Thomas Rohr ◽  
Hilke Wobst ◽  
Felix S. Schöpf ◽  
...  
Keyword(s):  
Fermentation Broth ◽  
High Titer ◽  
New Technology ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Expression Platform ◽  
Small Proteins ◽  
Production Platform ◽  
Β Amyloid ◽  
Cost Efficient

AbstractThe production of peptides as active pharmaceutical ingredients (APIs) by recombinant technologies is of emerging interest. A reliable production platform, however, is still missing due the inherent characteristics of peptides such as proteolytic sensitivity, aggregation and cytotoxicity. We have developed a new technology named Numaswitch solving present limitations. Numaswitch was successfully employed for the production of diverse peptides and small proteins varying in length, physicochemical and functional characteristics, including Teriparatide, Linaclotide, human β-amyloid and Serum amyloid A3. Additionally, the potential of Numaswitch for a cost-efficient commercial production is demonstrated yielding > 2 g Teriparatide per liter fermentation broth in a quality meeting API standard.

scholarly journals Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging

Molecules ◽  
2021 ◽  
Vol 26 (3) ◽  
pp. 610
Author(s):  
Mariann Inga Van Meter ◽  
Salah M. Khan ◽  
Brynne V. Taulbee-Cotton ◽  
Nathan H. Dimmitt ◽  
Nathan D. Hubbard ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Mass Spectrometry Imaging ◽  
Laser Desorption ◽  
Ionization Mass Spectrometry ◽  
Ionization Mass ◽  
Active Pharmaceutical Ingredients ◽  
Laser Desorption Ionization ◽  
Over The Counter ◽  
Pharmaceutical Ingredients ◽  
Desorption Ionization

Agglomeration of active pharmaceutical ingredients (API) in tablets can lead to decreased bioavailability in some enabling formulations. In a previous study, we determined that crystalline APIs can be detected as agglomeration in tablets formulated with amorphous acetaminophen tablets. Multiple method advancements are presented to better resolve agglomeration caused by crystallinity in standard tablets. In this study, we also evaluate three “budget” over-the-counter headache medications (subsequently labeled as brands A, B, and C) for agglomeration of the three APIs in the formulation: Acetaminophen, aspirin, and caffeine. Electrospray laser desorption ionization mass spectrometry imaging (ELDI-MSI) was used to diagnose agglomeration in the tablets by creating molecular images and observing the spatial distributions of the APIs. Brand A had virtually no agglomeration or clustering of the active ingredients. Brand B had extensive clustering of aspirin and caffeine, but acetaminophen was observed in near equal abundance across the tablet. Brand C also had extensive clustering of aspirin and caffeine, and minor clustering of acetaminophen. These results show that agglomeration with active ingredients in over-the-counter tablets can be simultaneously detected using ELDI-MS imaging.

scholarly journals Sulfanyl Porphyrazines with Morpholinylethyl Periphery—Synthesis, Electrochemistry, and Photocatalytic Studies after Deposition on Titanium(IV) Oxide P25 Nanoparticles

Molecules ◽  
2021 ◽  
Vol 26 (8) ◽  
pp. 2280
Author(s):  
Tomasz Koczorowski ◽  
Wojciech Szczolko ◽  
Anna Teubert ◽  
Tomasz Goslinski
Keyword(s):  
Diclofenac Sodium ◽  
2D Nmr ◽  
Oxide Nanoparticles ◽  
Electrochemical Studies ◽  
Macrocyclic Compounds ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Vis Spectroscopy ◽  
Singlet Oxygen Quencher ◽  
Nmr Techniques

The syntheses, spectral UV–Vis, NMR, and electrochemical as well as photocatalytic properties of novel magnesium(II) and zinc(II) symmetrical sulfanyl porphyrazines with 2-(morpholin-4-yl)ethylsulfanyl peripheral substituents are presented. Both porphyrazine derivatives were synthesized in cyclotetramerization reactions and subsequently embedded on the surface of commercially available P25 titanium(IV) oxide nanoparticles. The obtained macrocyclic compounds were broadly characterized by ESI MS spectrometry, 1D and 2D NMR techniques, UV–Vis spectroscopy, and subjected to electrochemical studies. Both hybrid materials, consisting of porphyrazine derivatives embedded on the titanium(IV) oxide nanoparticles’ surface, were characterized in terms of particle size and distribution. Next, they were subjected to photocatalytic studies with 1,3-diphenylisobenzofuran, a known singlet oxygen quencher. The applicability of the obtained hybrid material consisting of titanium(IV) oxide P25 nanoparticles and magnesium(II) porphyrazine derivative was assessed in photocatalytic studies with selected active pharmaceutical ingredients, such as diclofenac sodium salt and ibuprofen.

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