scholarly journals New liquid oral formulations of hydroxychloroquine: a physicochemical stability study

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Vincent Lebreton ◽  
Blandine Bourcier ◽  
Karine Cosson ◽  
Frédéric Lagarce ◽  
Laurence Spiesser-Robelet ◽  
...  
Keyword(s):  
Degradation Products ◽  
Storage Conditions ◽  
Stability Study ◽  
Physical Parameters ◽  
Suspension Stability ◽  
Liquid Form ◽  
Vehicle Suspensions ◽  
Stability Indicating Method ◽  
Oral Liquid ◽  
The Stability

Abstract Objectives Hydroxychloroquine (HCQ) presents many drug properties that increase its therapeutic use. There are, indeed, different research pathways in numerous autoimmune, inflammatory, and infectious diseases, as well as in cancerology. HCQ is only marketed as HCQ sulfate in film-coated or coated tablets for oral use. No pediatric liquid form is currently available on the market. The purpose of the present study is to develop oral liquid formulations for HCQ at 50 mg/mL with two different oral vehicle suspensions, namely ORA-Plus®/ORA-Sweet® (ORA) and Syrspend® SF PH 4 (SYR). Methods The suspension stability was assessed in different storage conditions (4 and 25 °C). A high-pressure liquid chromatography (HPLC) stability-indicating method with UV detection was developed to determine HCQ concentrations in the different formulations, and detect potential degradation products. Physical parameters, e.g. pH and osmolality were also monitored during the period of the stability study. Results HCQ concentration, osmolality, and pH remained stable for 90 days at 4 and 30 °C for HCQ in 50% ORA-Plus®/50% ORA-Sweet®. For HCQ suspension in SYR, the suspension remained stable 90 days at 4 °C and 60 days at 30 °C. Conclusions For all preparations, no significant physical or chemical modification was noticed during the period of the study.

scholarly journals Stability Study of Darunavir Ethanolate Tablets Applying a New Stability-Indicating HPLC Method

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Josilene Chaves Ruela Corrêa ◽  
Cristina Helena dos Reis Serra ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Degradation Products ◽  
Hplc Method ◽  
Stability Study ◽  
Raw Material ◽  
Forced Degradation ◽  
The Novel ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
The Stability ◽  
Darunavir Ethanolate

Chemical and physical degradation of drugs may result in altered therapeutic efficacy and even toxic effects. Therefore, the aim of this work was to study the stability of darunavir and to develop and validate a liquid chromatography (LC) method to determine darunavir in raw material and tablets in the presence of degradation products. The novel method showed to be linear from 6.0 to 21.0 μg/mL, with high precision (CV < 2%) and accuracy (recuperation of 99.64%). It is simple and reliable, free of placebo interferences. The robustness of the method was evaluated by a factorial design using seven different parameters. Forced degradation study was done under alkaline, acidic, and oxidative stress at ambient temperature and by heating. The LC method was able to quantify and separate darunavir and its degradation products. Darunavir showed to be unstable under alkaline, acid, and oxidative conditions. The novelty of this study is understanding the factors that affect darunavir ethanolate stability in tablets, which is the first step to unravel the path to know the degradation products. The novel stability-indicating method can be used to monitor the drug and the main degradation products in low concentrations in which there is linearity.

scholarly journals FORMULATION, CHARACTERIZATION AND STABILITY STUDY OF FAST DISSOLVING THIN FILM CONTAINING ASTAXANTHIN NANOEMULSION USING HYDROXYPROPYLMETHYL CELLULOSE POLYMER

2021 ◽  
pp. 17-22
Author(s):  
LUSI NURDIANTI ◽  
IYAN SOPYAN ◽  
TAOFIK RUSDIANA
Keyword(s):  
Thin Film ◽  
Mechanical Characteristics ◽  
Storage Conditions ◽  
Stability Study ◽  
Matrix System ◽  
Stability Studies ◽  
Casting Method ◽  
Hydroxypropylmethyl Cellulose ◽  
The Stability ◽  
Physical And Mechanical Characteristics

Objective: The present study was conducted to formulate and characterize the thin film containing astaxanthin nanoemulsion (TF-ASN) using Hydroxypropylmethyl Cellulose (HPMC) polymer as a film matrix system. The stability studies in different storage conditions were also performed. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using self-nanoemulsifying method, followed by incorporation into the HPMC matrix system by solvent casting method to forming TF-ASN. Evaluation of TF-ASN was performed by physical and mechanical characterizations. Stability study was carried out in both of accelerated (temperature of 40±2 °C/75±5% RH) and non-accelerated (at ambient temperature) conditions. Assay of astaxanthin in individual TF-ASN was determined compared to pure astaxanthin. Results: TF-ASN had good physical and mechanical characteristics that suitable for intraoral administration. Conclusion: For the study of stability under different storage conditions, it was proven that nanoemulsion form was packed in a HPMC matrix could enhance the stability of the astaxanthin.

scholarly journals FORMULATION, CHARACTERIZATION, AND DETERMINATION OF THE DIFFUSION RATE STUDY OF ANTIOXIDANT SERUM CONTAINING ASTAXANTHIN NANOEMULSION

2021 ◽  
pp. 200-204
Author(s):  
LUSI NURDIANTI ◽  
RISNA CLARA ◽  
HENDY SUHENDY ◽  
FAJAR SETIAWAN ◽  
KENI IDACAHYATI
Keyword(s):  
Diffusion Rate ◽  
Topical Administration ◽  
Storage Conditions ◽  
Stability Study ◽  
Gelling Agent ◽  
Rate Study ◽  
Antioxidant Characteristics ◽  
The Stability ◽  
Physical And Chemical ◽  
And Diffusion

Objective: Astaxanthin is one of the natural carotenoids with strong antioxidant characteristics which is widely used in skin care. The aim of this study was developed to formulate and characterize the antioxidant serum containing astaxanthin nanoemulsion and the diffusion rate studies using diffusion Franz method. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using the self-nanoemulsifying method, followed by incorporation into serum preparation with the using carbomer as a gelling agent. Evaluation of serum As-NE was performed by physical, chemical characterizations and diffusion assay. Stability study was carried out in both accelerated (temperature of 40±2 °C/75±5%RH) and non-accelerated (at ambient temperature) conditions. Results: These results suggest that antioxidant serum As-NE had good physical and chemical characteristics that are suitable for topical administration. Conclusion: For the study of diffusion and stability under different storage conditions, it was proven that antioxidant serum As-NE form was packed in a carbomer as a gelling agent that could enhance the stability and diffusion rate of the astaxanthin.

Long-term stability of ready-to-use 1-mg/mL midazolam solution

2020 ◽  
Vol 77 (9) ◽  
pp. 681-689
Author(s):  
Sixtine Gilliot ◽  
Morgane Masse ◽  
Frédéric Feutry ◽  
Christine Barthélémy ◽  
Bertrand Décaudin ◽  
...  
Keyword(s):  
High Performance ◽  
Detection Method ◽  
Degradation Products ◽  
Storage Conditions ◽  
Target Concentration ◽  
Long Term Stability ◽  
Ph Values ◽  
Particle Contamination ◽  
The Stability

Abstract Purpose Midazolam is a benzodiazepine derivative commonly used in intensive care units to control sedation. Its use requires dilution of a 5-mg/mL commercial solution to a target concentration of 1 mg/mL. A study was conducted to evaluate the stability of diluted ready-to-use 1-mg/mL midazolam solutions over 365 days when stored in cyclic olefin copolymer vials or polypropylene syringes. Methods A specific stability-indicating high-performance liquid chromatography coupled with UV detection method was developed for midazolam hydrochloride and validated for selectivity, linearity, sensitivity, precision, and accuracy. Three storage conditions were tested: –20°C ± 5°C, 5°C ± 3°C, and 25°C ± 2°C at 60% ± 5% relative humidity. Half of the vials were stored upside down to test for the absence of interaction between midazolam and the stopper. Particle contamination, sterility, and pH were assessed. Results The limit of stability was set at 90% of the initial concentration. After 1 year’s storage at –20°C and 5°C, concentrations remained superior to 90% under all storage conditions. At 25°C, stability was maintained up to day 90 in syringes (mean [SD], 92.71% [1.43%]) and to day 180 in upright and upside-down vials (92.12% [0.15%] and 91.57% [0.15%], respectively). No degradation products were apparent, no variations in pH values were detected, and containers retained their sterility and conformity with regard to any specific contamination during the study. Conclusion The evaluated 1-mg/mL midazolam solution was stable over a 1-year period when stored at a refrigerated (5°C) or frozen (–20°C) temperature in both vials and syringes; with storage at 25°C, the stability duration was lower. The preparation of ready-to-use midazolam solutions by a hospital pharmacy is compatible with clinical practice and could help to decrease risks inherent in dilution in care units.

Development and Validation of a Stability Indicating RP-HPLC Method for Hydrocortisone Acetate Active Ingredient, Propyl Parahydroxybenzoate and Methyl Parahydroxybenzoate Preservatives, Butylhydroxyanisole Antioxidant, and Their Degradation Products in a Rectal Gel Formulation

2015 ◽  
Vol 98 (1) ◽  
pp. 27-34 ◽  
Author(s):  
Magda Ascaso ◽  
Pilar Pérez-Lozano ◽  
Mireia García ◽  
Encarna García-Montoya ◽  
Montse Miñarro ◽  
...  
Keyword(s):  
Active Ingredient ◽  
Active Substance ◽  
Degradation Products ◽  
Gradient Elution ◽  
Hplc Method ◽  
Array Detector ◽  
Hydrocortisone Acetate ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
The Stability

Abstract A stability indicating method was established through a stress study, wherein different methods of degradation (oxidation, hydrolysis, photolysis, and temperature) were studied simultaneously to determine the active ingredient hydrocortisone acetate, preservatives propyl parahydroxybenzoate, and methyl parahydroxybenzoate, antioxidant butylhydroxyanisole (BHA), and their degradation products in a semisolid dosage gel form. The proposed method was suitably validated using a Zorbax SB-Phenyl column and gradient elution. The mobile phase consisted of a mixture of methanol, acetonitrile, and water in different proportions according to a planned program at a flow rate of 1.5 mL/min. The diode array detector was set at 240 nm for the active substance and two preservatives,and 290 nm for BHA. The validation study was conducted according to International Conference on Harmonization guidelines for specificity, linearity, repeatability, precision, and accuracy. The method was usedfor QC of hydrocortisone acetate gel and for the stability studies with the aim of quantifying the active substance, preservatives, antioxidant, and degradation products. It has proved to be suitable as a fast and reliable method for QC.

scholarly journals Stability of Hydrocortisone in Oral Powder Form Compounded for Pediatric Patients in Japan

Pharmaceutics ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1267
Author(s):  
Jumpei Saito ◽  
Nozomi Yoshikawa ◽  
Takehisa Hanawa ◽  
Ayuna Ozawa ◽  
Takahiro Matsumoto ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Degradation Products ◽  
Storage Conditions ◽  
Drug Dissolution ◽  
Powder Form ◽  
X Ray Diffraction ◽  
X Ray ◽  
Array Detection ◽  
The Stability

Hydrocortisone has been utilized in the management of adrenal insufficiency. For pediatric patients, the commercially available enteral form of hydrocortisone tablets (Cortoril®) is administered in powder form after being compounded by a pharmacist. However, the stability and quality of compounded hydrocortisone powder have not been verified. In this study, we formulated a 20 mg/g oral hydrocortisone powder by adding lactose monohydrate to crushed and filtered hydrocortisone tablets and assessed the stability and physical properties of this compounded product in polycarbonate amber bottles or coated paper packages laminated with cellophane and polyethylene. Stability was examined over 120 days in three storage conditions: closed bottle, in-use bottle, and laminated paper. Drug dissolution and powder X-ray diffraction analysis were conducted to assess its physicochemical stabilities. Validated liquid chromatography-diode array detection was used to detect and quantify hydrocortisone and its degradation products. Although impurity B (cortisone) and G (hydrocortisone-21-aldehyde) were found after 120 days of storage, no crystallographic and dissolution changes were noted. Hydrocortisone content was maintained between 90% and 110% of initial contents for 120 days at 25 ± 2 °C and 60 ± 5% relative humidity in all packaging conditions.

scholarly journals IMPURITY PROFILING OF FIRST LINE ANTI-TB DRUG-TERIZIDONE USING CHROMATOGRAPHIC AND RELATED TECHNIQUES

2021 ◽  
pp. 83-95
Author(s):  
PRAGATI J. VANAVI ◽  
SADHANA J. RAJPUT
Keyword(s):  
Formic Acid ◽  
Degradation Products ◽  
Storage Condition ◽  
Stability Study ◽  
Preparative Hplc ◽  
Esi Ms ◽  
Impurity Profiling ◽  
Stress Degradation ◽  
Bulk Drug ◽  
The Stability

Objective: The objective of the present study was to investigate the stability of TRZ against different stressors and to prepare impurity profile for potential impurities and degradation products (DPs) formed under stress degradation of TRZ bulk drug and formulation. Methods: Three analytical methods were developed; the stability-indicating method that was developed using HPLC instrument with 0.01M ammonium acetate buffer (pH 4.0 using glacial acetic acid (GAA)) and acetonitrile in gradient program. The second method was a UPLC/ESI-MS method using 0.1 % Formic acid in Milli Q water (pH= 2.70) and 0.1%Formic acid in Milli Q water: Acetonitrile (10:90) in gradient program for identification of TRZ and DPs while the third, preparative HPLC method was used for isolation of impurities using (A) 0.05% ammonia (NH3) in water and (B) Acetonitrile+20% mobile phase A in gradient sequence. Gradient sequences are described in the main text. Results: The analytical method for stability study was developed and validated using ICH (Q2) R1 guidelines. The result of stability study by stress degradation showed that TRZ was susceptible to degradation in acid (7 DPs), alkaline, neutral (9 DPs) and oxidative conditions (10 DPs); major DPs were identified (where it was possible) and the chemical structure was elucidated by combining the data of ESI/MS, NMR and/or Tandem MS. The Impurity profiling was completed by reporting all the DPs, either major or minor for TRZ bulk drug and formulation. Conclusion: The complete Impurity profiling for TRZ is reported for the first time in literature. The study data would be add-on for formulation storage condition and further development.

scholarly journals Analytical Separation and Characterisation of Degradation Products and the Development and Validation of a Stability-Indicating Method for the Estimation of Impurities in Levosalbutamol Respules Formulation

2017 ◽  
Vol 2 (03) ◽  
pp. 83-92
Author(s):  
Anas Rasheed ◽  
Osman Ahmed
Keyword(s):  
Limit Of Detection ◽  
Degradation Products ◽  
Drug Product ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Ich Guidelines ◽  
Stress Study ◽  
The Stability ◽  
Development And Validation

A short selective, precise, accurate and sensitive stability-indicating gradient LC-MS/MSn method was developed for the quantitative determination of process-related impurities and degradation products of Levosalbutamol in pharmaceutical respules formulations. During the stress study, the degradation products of Levosalbutamol were well-resolved from Levosalbutamol and its impurities and the mass balances were found to be satisfactory in all the stress conditions, thus proving the stability-indicating capability of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, ruggedness, and robustness. During the stability analysis of the drug product, one unknown impurity was detected by the above stability-indicating method. The flow rate was 0.8 ml/min and effluent was monitored at 242nm. Retention time was found to be 2.237±0.08 min. The LOD and LOQ values were found to be 0.20984 (μg/ml) and 0.6359 (μg/ml) respectively.

scholarly journals Analytical Separation and Characterisation of Degradation Products and the Development and Validation of a Stability-Indicating Method for the Estimation of Impurities in Ipratropium Bromide Respules Formulation

2017 ◽  
Vol 2 (03) ◽  
Author(s):  
Anas Rasheed ◽  
Osman Ahmed
Keyword(s):  
Ipratropium Bromide ◽  
Limit Of Detection ◽  
Degradation Products ◽  
Drug Product ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Ich Guidelines ◽  
Stress Study ◽  
The Stability ◽  
Development And Validation

A short selective, precise, accurate and sensitive stability-indicating gradient LC-MS/MSn method was developed for the quantitative determination of process-related impurities and degradation products of Ipratropium bromide in pharmaceutical respules formulations. During the stress study, the degradation products of Ipratropium bromide were well-resolved from Ipratropium bromide and its impurities and the mass balances were found to be satisfactory in all the stress conditions, thus proving the stability-indicating capability of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, ruggedness, and robustness. During the stability analysis of the drug product, one unknown impurity was detected by the above stability-indicating method. The flow rate was 0.5 ml/min and effluent was monitored at 242nm. Retention time was found to be 5.0150.15 min. The LOD and LOQ values for were found to be 0.20996 (?g/ml) and 0.63624 (?g/ml) respectively.

scholarly journals Stability-Indicating HPLC Method for isoflavones aglycones analysis from Trifolium pratense L. extract

2020 ◽  
Vol 4 (1) ◽  
pp. 28-38
Author(s):  
Simony Martiny ◽  
Mairique Waszczuk ◽  
Samuel Kaiser ◽  
Marina Cardoso Nemitz ◽  
Valquiria Linck Bassani
Keyword(s):  
Hplc Analysis ◽  
Trifolium Pratense ◽  
Degradation Products ◽  
Hplc Method ◽  
Alkaline Media ◽  
Biochanin A ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
The Stability

The purpose of this study was to develop and validate a fast HPLC stability-indicating method for simultaneously quantifying the four main isoflavones in Trifolium pratense. Validation procedures followed the ICH requirements for complex matrices. The stability-indicating tests were performed by exposing the isoflavones to conditions of forced degradation and further analysis for verifying the formation of degradation products and their possible interferences in the HPLC analysis. The major isoflavones of Trifolium pratense proved to be stable against acid and oxidative media, thermodegradation, and photodegradation. However, they proved to be unstable in alkaline media, even for short periods of exposure like 2h. In this condition, in addition to the peaks corresponding to isoflavones, the HPLC analysis showed the presence of three additional peaks which were eluted at different retention times to the reference substances, without interfering in the quantification of the four analytes of interest, formononetin, biochanin A, daidzein and genistein. The method was validated following ICH guidelines showing to be specific, linear, precise, accurate, and robust.This first report concerning a stability-indicating method revealed that the proposed HPLC method reliably quantify the isoflavones and separate them from the degradation products in a short time of analysis.

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