scholarly journals FEATURES OF THE DEVELOPMENT OF A LYOPHILIZED INJECTABLE DOSAGE FORM OF THE ORIGINAL ANTICANCER DRUG LCS-1208

2021 ◽  
pp. 102-105
Author(s):  
ILYA GULYAKIN ◽  
ANNA LANTSOVA ◽  
LYUDMILA NIKOLAEVA ◽  
MARIA DMITRIEVA ◽  
NATALIYA OBOROTOVA ◽  
...  
Keyword(s):  
Freeze Drying ◽  
Dosage Form ◽  
Freezing Temperature ◽  
Antitumor Drug ◽  
Secondary Drying ◽  
Filter Unit ◽  
Series Of Experiments ◽  
Drying Chamber ◽  
Injectable Dosage

Objective: Development of a lyophilized injectable dosage form LCS-1208, an original antitumor drug based on an indolocarbazole derivative. Methods: The prepared solution of the injectable dosage form LCS-1208 is transferred to sterilizing filtration, which is carried out under vacuum on a «Stericup» filter unit with a filter pore size of 0.22 μm. The sterile solution of the injectable dosage form LCS-1208 is poured into sterile vials using a dispenser and lyophilized in a freeze-drying chamber. At the end of drying, the preparation is corked in the chamber of a sublimation unit using a hydraulic device and transferred to crimping with aluminum caps using a seaming machine. Quantitative determination of the drug content was determined by spectrophotometry using a standard sample at λ = 320±2 nm. The pH was determined by potentiometry. Results: A freeze-drying regimen for the injectable dosage form LCS-1208 has been developed. The required solution freezing temperature was established taking into account the presence of 2 eutectic zones: a solution of LCS-1208 in DMSO (-35 ÷-32) °С, an aqueous solution of Kollidon 17PF (-10 ÷-8) °С. As a result of a series of experiments, the optimal lyophilization regime was chosen that does not require preliminary freezing in a low-temperature chamber, with freezing on the shelves of freeze-drying at a temperature of-47 °C without their preliminary cooling. The most acceptable vial filling volume was determined, amounting to 3 ml, and the rate of temperature rise during secondary drying of the preparation was justified. When using the developed regime of lyophilization of the LCS-1208 solution, it was shown that it can be sublimated while preserving the initial qualitative and quantitative characteristics. Conclusion: In this article, using the example of creating a lyophilized injectable dosage form LCS-1208 (the original antitumor drug from the indolocarbazole group), the main problems that arose during the lyophilization of the selected composition of the model solution, as well as ways to improve the process.

scholarly journals Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

Molecules ◽  
2021 ◽  
Vol 26 (21) ◽  
pp. 6597
Author(s):  
Jesús Alberto Afonso Urich ◽  
Viktoria Marko ◽  
Katharina Boehm ◽  
Raymar Andreína Lara García ◽  
Dalibor Jeremic ◽  
...  
Keyword(s):  
Dosage Form ◽  
Gradient Elution ◽  
Quality Data ◽  
Acetonitrile Solution ◽  
Forced Degradation ◽  
Solution Stability ◽  
Stability Indicating ◽  
The Impact ◽  
Injectable Dosage

A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analytical quality by design (AQbD) principles, which are aligned with the future requirements from the regulatory agencies using AQbD principles. The method was developed by assessing the impact of ion pairing, the chromatographic column, pH and gradient elution. The development was achieved with a Waters Acquity HSS T3 (50 × 2.1 mm i.d., 1.8 µm) column at ambient temperature, using sodium dihydrogen phosphate 5 mM + octane-1-sulphonic acid sodium salt 10 mM buffer pH 3.0 (Solution A) and acetonitrile (Solution B) as mobile phases in gradient elution (t = 0 min, 5% B; t = 1 min, 5% B; t = 5 min, 50% B; t = 7 min, 5% B; t = 10 min, 5% B) at a flow rate of 0.5 mL/min and UV detection of 280 nm. The linearity was proven for hexoprenaline over a concentration range of 3.50–6.50 µg/mL (R2 = 0.9998). Forced degradation studies were performed by subjecting the samples to hydrolytic (acid and base), oxidative, and thermal stress conditions. Standard solution stability was also performed. The proposed validated method was successfully used for the quantitative analysis of bulk, stability and injectable dosage form samples of the desired drug product. Using the AQbD principles, it is possible to generate methodologies with enhanced knowledge, which can eventually lead to a reduced regulatory risk, high quality data and lower operational costs.

scholarly journals LYOPHILIZED INJECTION: A MODERN APPROACH OF INJECTABLE DOSAGE FORM

2018 ◽  
Vol 8 (5) ◽  
pp. 10-18
Author(s):  
U Sheena ◽  
KG Parthiban ◽  
R Selvakumar
Keyword(s):  
Patient Compliance ◽  
Freeze Drying ◽  
Dosage Form ◽  
Dosage Forms ◽  
Solid Dosage Forms ◽  
Modern Approach ◽  
Solid Dosage ◽  
Liquid Injection ◽  
Improved Stability ◽  
Injectable Dosage

Now-a-days, lyophilized injection dosage form is extensively used to improve the bioavailability, stability, solubility and patient compliance. The lyophilized injection has considered as alternative to oral solid dosage forms for better patient compliance especially in bed ridden patients and for attaining maximum bioavailability, improved stability. The lyophilized injection reconstitute before injection to produce liquid injection. This review includes a detailed updated concept on lyophilized injection. Keywords: Lyophilized injection, parenteral, freeze drying

RP-HPLC determination of pazufloxacin in injectable dosage form

2013 ◽  
Vol 7 (2) ◽  
pp. 172-174
Author(s):  
Kalaichelvi Ramalingam ◽  
Jayachandran Ekambaram
Keyword(s):  
Dosage Form ◽  
Hplc Determination ◽  
Rp Hplc ◽  
Injectable Dosage

The Effect of Stress and Warfarin on the Adrenal Gland in Relation to Spontaneous Hemorrhage, as Judged by Measurement of Adrenal Ascorbic Acid and Serum Corticosterone

1971 ◽  
Vol 26 (02) ◽  
pp. 275-288 ◽  
Author(s):  
S Chattopadhyay ◽  
D. D Johnson ◽  
G. J Millar ◽  
L. B Jaques
Keyword(s):  
Ascorbic Acid ◽  
Acid Concentration ◽  
Ascorbic Acid Concentration ◽  
Corticosterone Concentration ◽  
Serum Corticosterone ◽  
Spontaneous Hemorrhage ◽  
Combined Action ◽  
Series Of Experiments ◽  
Pituitary Adrenal Axis

SummaryRats were subjected to the following procedures: No treatment, Stressor (10% NaCl i.p.), Warfarin for 7 days, Stressor followed by Warfarin; and groups were sacrificed at intervals for assessment of spontaneous hemorrhage and of adrenal ascorbic acid concentration. There was no hemorrhage in the no treatment and stressor groups; some hemorrhage in the warfarin group; profound hemorrhage with Warfarin + Stressor. The adrenal ascorbic acid concentration was found to be lower, 8 h and again 5 days after stress, and remained lower in the warfarin + stress animals. Warfarin had no effect on adrenal ascorbic acid level.In another series of experiments in which the stress consisted of an electric current to the cage floor for 6 sec over 15 min, rats were sacrificed daily for determination of serum corticosterone concentration and occurrence of spontaneous hemorrhage. There was a statistically significant increase of serum corticosterone concentration with stress, warfarin and combined warfarin and stress treatments (P< 0.001 for all three variables). There was a significant correlation (r = 0.96 and 0.89, P< 0.01) for serum corticosterone concentration with hemorrhage score and incidence of hemorrhage in stressed rats receiving warfarin, but not in those receiving only warfarin. The results indicate an activation, rather than an exhaustion, of the pituitary-adrenal axis during the combined action of anticoagulant and stress, which results in the development of spontaneous hemorrhage.

High-performance thin-layer chromatographic determination of rosiglitazone in its dosage form

2002 ◽  
Vol 15 (3) ◽  
pp. 192-195 ◽  
Author(s):  
Ramesh Sane ◽  
Mary Francis ◽  
Atul Moghe ◽  
Sachin Khedkar ◽  
Ajit Anerao
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Determination

Spectrophotometric Determination of Alendronate Sodium by using Sodium-1,2-Naphthoquinone-4-Sulphonate

2012 ◽  
Vol 4 (4) ◽  
pp. 1563-1568
Author(s):  
Sagar Suman Panda ◽  
Ravi Kumar B V V ◽  
D Patanaik
Keyword(s):  
Spectrophotometric Method ◽  
Absorption Maximum ◽  
Dosage Form ◽  
Dosage Forms ◽  
Alendronate Sodium ◽  
Colored Complex ◽  
Pharmaceutical Dosage Forms ◽  
Recovery Study ◽  
Assay Conditions

A simple, precise and accurate spectrophotometric method was developed for analysis of the osteoporesis drug alendronate sodium (ALS). The method is based on reaction of the drug with sodium-1,2-naphthoquinone-4-sulphonate (NQS) in presence of alkali to form a brown colored complex giving absorption maximum at 525 nm. The drug obeyed Beer’s law in the range of 5-70 µg/ml with a correlation coefficient of 0.999. The LOD and LOQ values are 1.7 µg/ml and 5.0 µg/ml, respectively. The average recoveries for recovery study were found to be in the range of 99.37%-100.46%. The R.S.D. values for intraday and inter-day precision were found to be 0.48 and 0.62, respectively. The optimized assay conditions were applied successfully for determination of ALS in pharmaceutical dosage forms. No interference was observed from the excipients present in the dosage form. The method is statistically validated as per the ICH requirements.  

Influence of Freeze-Drying Modes on the Quality of Live Plague Vaccine

2019 ◽  
Vol 35 (4) ◽  
pp. 73-78
Author(s):  
S.E. Gostischeva ◽  
D.V. Rostovtseva ◽  
G.F. Ivanova ◽  
A.V. Kostrominov ◽  
M.V. Pilipenko
Keyword(s):  
Heating Rate ◽  
Freeze Drying ◽  
Eutectic Point ◽  
Freezing Temperature ◽  
Freezing Time ◽  
Residual Moisture ◽  
High Viability ◽  
Plague Vaccine ◽  
Selection Of

The optimization of the drying schedule has been carried out to improve the quality indicators of the live plague vaccine. Based on the data obtained on the eutectic point of the vaccine suspension, the freezing temperature and freezing time were set to -50 °С and 6-7 h, respectively. A pressure of 40 mTorr over the surface of the drying suspension and 20 mTorr during the desorption were shown to be the best conditions for sublimation. The drying tests with different options for the shelf heating rate, vacuum depth and duration of intermediate temperature indicators were carried out to develop the improved freeze-drying mode providing the selection of the most adapted bacteria. A vaccine lyophilized under the developed conditions has low residual moisture (up to 2%) and high viability index that persists over the whole shelf life. lyophilization, sublimation, eutectic, live plague vaccine, residual moisture, viability

Ion Selective Electrodes for Potentiometric Determination of Tizanidine in Its Pharmaceutical Dosage Form

2016 ◽  
Vol 12 (3) ◽  
pp. 177-184 ◽  
Author(s):  
Gamal Abdel-Hafiz Mostafa ◽  
Mohammed Hefnawy ◽  
Mohammed Abounassif ◽  
Amer Alanazi ◽  
Abdulrahman Al-Majed ◽  
...  
Keyword(s):  
Dosage Form ◽  
Potentiometric Determination ◽  
Ion Selective Electrodes ◽  
Pharmaceutical Dosage Form

A Green Liquid Chromatographic Method For The Simultaneous Determination of Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride and Propyphenazone

2019 ◽  
Vol 15 (6) ◽  
pp. 635-641
Author(s):  
Nadia M. Mostafa ◽  
Ghada M. Elsayed ◽  
Nagiba Y. Hassan ◽  
Dina A. El Mously
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Green Analytical Chemistry ◽  
Chlorpheniramine Maleate ◽  
Accuracy And Precision ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

Background:The concept of green analytical chemistry prevails due to the growing environmental pollution.Objective:Our attempts are to develop simple and eco-friendly method which is non-harmful to the environment by producing minimal waste. In this context, a green liquid chromatographic method was applied for the simultaneous determination of chlorpheniramine maleate, pseudoephedrine hydrochloride and propyphenazone in their combined dosage form.Methods:Separation was carried out using X select HSS RP C18 analytical column (250 × 4.6 mm, 5μm) using methanol - 0.02 M phosphate buffer pH 3 - triethylamine (60:40: 0.1, by volume) as a mobile phase. The separated peaks were detected at 215 nm at a flow rate 1.0 mL/min.Results:Quantification was done over the concentration ranges of 1-25 µg/mL for chlorpheniramine maleate, 5-35 µg/mL for pseudoephedrine hydrochloride and 10-120 µg/mL for propyphenazone. The suggested method was validated with regard to linearity, accuracy and precision according to the International Conference on Harmonization guidelines with good results.Conclusion:It could be used as a safer alternative for routine analysis of the mentioned drugs in quality control laboratories.

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