Kinetics study of hydrochlorothiazide lactose liquid state interaction using conventional isothermal arrhenius method under basic and neutral conditions

Ghaderi, Faranak; Nemati, Mahboob; Siahi-Shadbad, Mohammad Reza; Valizadeh, Hadi; Monajjemzadeh, Farnaz

doi:10.1590/s1984-82502016000400015

Cited by 4 publications

(3 citation statements)

References 14 publications

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“…DSC curve of acarbose shows the presence of an endothermic event at 221°C, which can be related to acarbose melting accompanied by decomposition. [18][19][20][21] Figure 2-B demonstrates the DSC curves of the binary mixtures of acarbose with incompatible excipients (PEG: Poly ethylene glycol, MgSt: Magnesium stearate, Eud: Eudragit, Na CMC: Sodium carboxy methyl cellulose). DSC curve of PEG2000 shows the presence of an endothermic event in 53°C caused by excipient melting and an exothermic event in 278°C.…”

Section: Differential Scanning Calorimetrymentioning

confidence: 99%

Evaluation of Pharmaceutical Compatibility between Acarbose and Common Excipients Used in the Development of Controlled Release Formulations

Gholizadeh-Hashjin¹,

Shabani²,

Monajjemzadeh³

2020

Pharm Sci

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Background: Excipients are used in the formulation of pharmaceutical dosage forms, but mayinteract with active pharmaceutical ingredients (APIs). Some of these interactions could alterthe physicochemical properties of the APIs which can affect the therapeutic efficacy and safety.Acarbose is an anti-diabetic drug used in this study as an API to investigate its compatibility withcommon excipients in order to development of pharmaceutical controlled release formulations. Methods: For this purpose, 15 different excipients were selected. Binary mixtures of drug witheach of the excipients (1:1 mass ratio) were prepared. Mixtures were analyzed immediately aftermixing and also after incubation at stress conditions (adding 20% water and incubated at 40°Cfor 2 months). The thermal analytical investigation like differential scanning calorimetry (DSC),Fourier transform infra-red spectroscopy (FTIR) and high-performance liquid chromatography(HPLC) were employed for physicochemical evaluations of the possible incompatibility.Photodiode-array (PDA) and mass studies were performed to ensure the peak purity of theHPLC peaks of API in stressed samples. Results: Incompatible excipients with acarbose were determined as EC (ethyl cellulose),Carbopol 934, Hydroxypropyl cellulose, PEG2000 (Polyethylene Glycol 2000), Mg Stearate, NaAlginate and Poloxamer. Conclusion: Results of this study would be used for the development of controlled releaseformulation of acarbose. It is recommended to avoid the use of incompatible excipients.

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Section: Differential Scanning Calorimetrymentioning

confidence: 99%

Evaluation of Pharmaceutical Compatibility between Acarbose and Common Excipients Used in the Development of Controlled Release Formulations

Gholizadeh-Hashjin¹,

Shabani²,

Monajjemzadeh³

2020

Pharm Sci

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“…The most common kinetic model for degradation reactions in solutions in pharmaceutical studies is the first-degree model in which the reaction rate depends on the initial concentration of the substance; the equation of this reaction follows the calculation of the natural logarithm of the concentrations. 20 Furthermore, the first-order reaction model indicates that the degradation reaction is a simple reaction. According to results, the best model for oxidative degradation of KA and Kadp by H 2 O 2 was determined to be the first-order model.…”

Section: Discussionmentioning

confidence: 99%

Comparative Stability of Two Anti-Hyperpigmentation Agents: Kojic Acid as a Natural Metabolite and Its Di-Palmitate Ester, Under Oxidative Stress; Application to Pharmaceutical Formulation Design

et al. 2021

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Purpose: Kojic acid a natural metabolite (KA) and its dipalmitate ester, kojic acid dipalmitate (Kadp) are both prescribed to treat skin hyperpigmentation. Stress test reveals the intrinsic stability of active ingredients and leads to selection of the suitable formulations. This research evaluates the comparative stability of KA and its di-palmitate ester under liquid oxidative stress. Methods: The HPLC-UV/PDA method with a C18 column was utilized. Liquid oxidative stress was induced using hydrogen peroxide (H2O2). Degradation was separately induced for each drug, and they were compared to each other. Results: Kadp degraded more rapidly in similar liquid oxidative stress conditions than KA did. The superior degradation model was the first order for both drugs based on the MPE values, indicating the dependency of the reaction rate on the initial concentration of the reactive substance. Ring opening was proposed as the most possible theory for KA and Kadp oxidative degradation. Conclusion: It is suggested to use KA instead of Kadp in less stable formulations, such as extemporaneous preparations. The incorporation of antioxidant excipients in Kadp formulations is recommended for yielding better stability results. Formulating Kadp in the internal phase of o/w emulsion formulations may protect this susceptive molecule from oxidative degradation during the shelf life of the pharmaceutical preparation. Further studies are required to study the exact mechanism of the degradation process.

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“…The Arrhenius equation is used to obtain K and Ea values which describe the velocity of vesicle decomposition and the minimum energy of chemical reactions. Besides that, it can also be used to calculate the shelf life of a drug with a formula according to the release kinetics model [20,21].…”

Section: Determination Of Kinetic Constants and Shelf Lifementioning

confidence: 99%

Effect of Stirring Speed and Stirring Time on Characterization of Clindamycin HCL Ethosomal and Ich Q1a (R2) Stability Test

APRIANI

2023

FARMACIA

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Clindamycin HCl is an antibiotic with limited bioavailability ranging from 0.7% to 12.9% of the applied dose. The ethosomal delivery system can increase the bioavailability of clindamycin HCl. However, in the manufacturing process, the speed and time of stirring are essential factors that affect the characterization of the resulting ethosomes. This study aims to optimize the clindamycin HCl ethosomal formula by varying the stirring speed (7,600 and 15,000 rpm) and stirring time (15 and 30 minutes) using ultra-turrax with a 2 2 factorial design method. The ethosomal formula was characterized including entrapment efficiency, particle size, polydispersity index and potential zeta. The optimum formula was tested for stability according to the ICH Q1A (R2) standard. The optimum formula was obtained at a stirring speed of 7,600 rpm and a stirring time of 15 minutes with an entrapment efficiency percentage of 72.38 ± 0.36%, a particle size of 270.80 ± 8.69 nm, a polydispersity index of 0.111 ± 0.032 and a potential zeta of -31.21 ± 0.82 mV. The results of the ICH Q1A (R2) stability test showed that the release model of the active substance followed order 0, the activation energy was 4.232 cal/mol, the kinetic constant was 9.897/day with a shelf life of 7.293 days at 25 ± 2°C/60 ± 5% RH and 8.247 days at 5 ± 3°C. RezumatClindamicina clorhidrat este un antibiotic cu biodisponibilitate limitată, variind de la 0,7% până la 12,9% din doza aplicată. Sistemul de eliberare etosomal poate crește biodisponibilitatea clindamicinei clorhidrat. Cu toate acestea, în procesul de fabricație, viteza și timpul de agitare sunt factori esențiali care afectează caracterizarea etosomilor rezultați. Acest studiu își propune să optimizeze formula etosomală pe bază de clindamicină HCl prin varierea vitezei de agitare (7.600 și 15.000 rpm) și a timpului de agitare (15 și 30 de minute), folosind dispersor cu o metodă de proiectare cu 2 2 factori. Formula etosomală a fost caracterizată incluzând eficiența de captare, dimensiunea particulelor, indicele de polidispersitate și potențialul zeta. Formula optimă a fost testată pentru stabilitate conform ghidului ICH Q1A (R2). Formula optimă a fost obținută la o viteză de agitare de 7.600 rpm și un timp de agitare de 15 minute, cu o eficiență de captare de 72,38 ± 0,36%, o dimensiune a particulei de 270,80 ± 8,69 nm, un indice de polidispersie de 0,1111 ± 0,032, și un potențial zeta de -31,21 ± 0,82 mV. Rezultatele testului de stabilitate ICH Q1A (R2) au arătat că modelul de cedare a substanței active a urmat cinetica de ordinul 0, energia de activare a fost de 4,232 cal/mol, constanta cinetică a fost de 9,897/zi cu o durată de valabilitate de 7,293 zile la 25 ± 2°C/60 ± 5% RH și 8,247 zile la 5 ± 3°C.

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Kinetics study of hydrochlorothiazide lactose liquid state interaction using conventional isothermal arrhenius method under basic and neutral conditions

Cited by 4 publications

References 14 publications

Evaluation of Pharmaceutical Compatibility between Acarbose and Common Excipients Used in the Development of Controlled Release Formulations

Evaluation of Pharmaceutical Compatibility between Acarbose and Common Excipients Used in the Development of Controlled Release Formulations

Comparative Stability of Two Anti-Hyperpigmentation Agents: Kojic Acid as a Natural Metabolite and Its Di-Palmitate Ester, Under Oxidative Stress; Application to Pharmaceutical Formulation Design

Effect of Stirring Speed and Stirring Time on Characterization of Clindamycin HCL Ethosomal and Ich Q1a (R2) Stability Test

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