Dissolution kinetics of glass fibres in saline solution: in vitro persistence of a sparingly soluble aluminium-rich leached layer

1995 ◽  
Vol 30 (22) ◽  
pp. 5691-5699 ◽  
Author(s):  
P. Baillif ◽  
B. Chouikhi ◽  
L. Barbanson ◽  
J. C. Touray
Keyword(s):  
Saline Solution ◽  
Dissolution Kinetics ◽  
Glass Fibres ◽  
Kinetics Of

scholarly journals Assessment of in Vitro Comparative Dissolution Kinetics of Moxonidine Products as a Factor Potentially Determining Effectiveness of Antihypertensive Treatment

2019 ◽  
Vol 14 (6) ◽  
pp. 951-957
Author(s):  
G. V. Ramenskaya ◽  
I. E. Shokhin ◽  
N. I. Gaponova ◽  
V. R. Abdrakhmanov
Keyword(s):  
Generic Drugs ◽  
Dissolution Kinetics ◽  
Acetate Buffer Solution ◽  
Medicinal Products ◽  
Buffer Solution ◽  
Reference Drug ◽  
Similarity Factor ◽  
Kinetics Of ◽  
Comparative Dissolution

Aim. Investigation of comparative dissolution kinetics of generic medicinal products containing moxonidine versus reference drug. Material and methods. Objects of the research were film-coated tablets containing moxonidine (INN) in a dose 0.4 mg: a reference drug Physiotens® and 4 generic drugs. In vitro dissolution test of moxonidine from the study drugs was performed using comparative dissolution kinetics test (CDKT). The CDKT was performed in the media with the following pH: 1.2 (1:9 mixture of 0.1 M hydrochloric acid and water), 4.5 (acetate buffer solution, prepared as per State Pharmacopoeia, XIII), and 6.8 (phosphate buffer solution, prepared as per State Pharmacopoeia, XIII). The sampling for dissolved moxonidine was performed 5, 10, 15, 20, and 30 min after the test was started. An high performance liquid chromatography method with ultraviolet detection at 220 nm was used to assay. Results. Within 15 min more that 85% of moxonidine dissolved from the reference drug and all study drugs at pH 1.2; dissolution profiles were similar without calculation of similarity factor f2. Similarly, at pH 4.5 dissolution profiles of study drugs #2 and #3 were similar to that of the reference drug, and the similarity factor f2 was not calculated. However, in case of study drugs #1 and #4 significant differences were observed at a single time point (15 min), which suggests that their dissolution profiles are non-similar to that of the reference drug. Similarity factors f2 were calculated 17.52 and 35.30, respectively (less than 50). At pH 6.8 similarity factors f2 for all study generic drugs were also less than 50 (23.8, 49.8, 38.6, and 35.9), so their dissolution curves were non-similar to that of reference drug. Conclusion. In our study we observed difference in release in vitro of medicinal products containing moxonidines: none of the study drugs was fully similar to the reference drug in all media. The differences observed at pH 6.8 were noteworthy, where the samples had or faster kinetics (study drugs #2 and #3), or slower dissolution kinetics (test drugs #1 and #4). Observed differences in moxonidine release rate may impact absorption of active pharmaceutical ingredient into the blood following drug administration.

scholarly journals In Vitro Dissolution Kinetics of Amlodipine Tablets Marketed in Russia Under Biowaiver Conditions

2010 ◽  
Vol 17 (3) ◽  
pp. 20-22 ◽  
Author(s):  
I. E. Shohin ◽  
G. V. Ramenskaya ◽  
G. F. Vasilenko ◽  
E. A. Malashenko
Keyword(s):  
Dissolution Kinetics ◽  
In Vitro Dissolution ◽  
Kinetics Of

Passive dissolution kinetics of titanium in vitro

1993 ◽  
Vol 4 (2) ◽  
pp. 117-126 ◽  
Author(s):  
K. E. Healy ◽  
P. Ducheyne
Keyword(s):  
Dissolution Kinetics ◽  
Kinetics Of

scholarly journals Comparative studies of the kinetics of dissolution of medicines on the basis of clopidogrel

2021 ◽  
pp. 26-34
Author(s):  
O. P. Baula ◽  
O. O. Saliy ◽  
V. I. Bessаrabov ◽  
A. М. Gerasimchuk
Keyword(s):  
Comparative Studies ◽  
Generic Drugs ◽  
Dissolution Kinetics ◽  
Dissolution Test ◽  
Generic Medicines ◽  
Dissolution Medium ◽  
Clopidogrel Bisulfate ◽  
Kinetics Of Dissolution ◽  
Kinetics Of

Generic medicines occupy dominant positions both in the pharmaceutical market of Ukraine and in industrial production by domestic pharmaceutical enterprises. The use of generic drugs in medical practice is of significant medical and social importance for expanding the accessibility of the general population to essential drugs. In Ukraine, more than twenty generic medicines based on clopidogrel, both foreign and domestic, are registered. All generic drugs containing clopidogrel bisulfate must comply with pharmaceutical bisulfate must comply with pharmaceutical equivalence, the kinetics of release of the active pharmaceutical ingredient using the Dissolution test in vitro, and pharmacokinetic parameters in vivo. The aim of the work was to carry out comparative studies of the dissolution kinetics of four samples of generic drugs based on clopidogrel with the dissolution kinetics of the original drug Plavix®, to evaluate the similarity factor of dissolution profiles and to determine the effect of biopharmaceutical factors on the equivalence of generics. Comparative studies of the kinetics of dissolution were carried out by the in vitro method according to the «Dissolution» test using a device with a blade with a rotation speed of 50 rpm, a dissolution medium with a pH value of 2.0 in a volume of 900 ml at a temperature of 37 ± 1 °C. The determination of the quantitative content of clopidogrel, which passed into the dissolution medium, was carried out by the method of adsorption spectrophotometry in the ultraviolet region at a wavelength of about 240 ± 2 nm. Based on the data obtained, the dissolution profiles of the original drug Plavix® and the studied samples of generic drugs were constructed, the similarity of which was assessed by the value of the similarity factor. According to the research results, it was found that one sample of the generic drug proved its equivalence by the in vitro method to Plavix®, and three other samples of generics had differences in dissolution kinetics in comparison with the original drug. Biopharmaceutical factors were analyzed that could affect the dissolution kinetics of the studied generic drugs, from which the physicochemical characteristics of clopidogrel bisulfate, the qualitative and quantitative composition of excipients and the features of the technological process were determined. Thus, on the basis of the comparative studies of the dissolution kinetics of drugs based on clopidogrel, generics were found that did not correspond to the in vitro equivalence according to the Dissolution test to the original drug, which could be due to the influence of a combination of biopharmaceutical factors.

scholarly journals Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro

Pharmacia ◽  
2022 ◽  
Vol 69 (1) ◽  
pp. 61-67
Author(s):  
Nataliia Shulyak ◽  
Kateryna Liushuk ◽  
Oksana Semeniuk ◽  
Nadiya Yarema ◽  
Tetyana Uglyar ◽  
...  
Keyword(s):  
Intestinal Permeability ◽  
Dosage Form ◽  
Phosphate Buffer Solution ◽  
Dissolution Kinetics ◽  
Acetate Buffer Solution ◽  
Buffer Solution ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Kinetics Of

Atorvastatin and lisinopril are a successful combination for the treatment of patients with chronic heart failure and hypertension. Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro were described. In medium with hydrochloric acid pH 1.2, in the medium of acetate buffer solution with a pH of 4.5 and in the medium phosphate buffer solution with a pH of 6.8 for 15 min more than 85% of the active substance passes into solution, hence the dissolution profiles these drugs in these environments are similar, and the drugs in them are “very quickly soluble”. Among the in vitro models that make it possible to assess the degree of absorption of API, the most widely used culture of adenocarcinoma cells of the colon – Caco-2. The development of the analytical methodology and its validation is the final stage of both the dissolution study and the Caco-2 test, as well as the biowaver procedure. It plays the most important role in the reliability of the results for all the above procedures and tests. To study permeability, method LC-MS/MS was developed. According to the obtained results, atorvastatin and lisinopril showed low permeability. The values ​​of recovery of transport of test and control substances through the monolayer of cells of the Caco-2 line indicate that the results of the experiment can be considered reliable. The equivalence of the drugs “Lisinopril”, tablets of 10 mg and “Atorvastatin”, tablets of 10 mg, belongs to class III BCS proven by in vitro studies.

scholarly journals HPLC method development and in vitro dissolution kinetics of amlodipine tablets under biowaiver conditions

2020 ◽  
Vol 10 (5) ◽  
pp. 6513-6521
Keyword(s):  
Method Development ◽  
Dissolution Kinetics ◽  
In Vivo Studies ◽  
In Vitro Dissolution ◽  
Pharmacokinetic Studies ◽  
Dissolution Profile ◽  
Pharmaceutical Dosage Forms ◽  
Kinetics Of

A biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent. The biowaiver approach based on BCS is intended to replace bioequivalence in vivo studies. The aim of the study was to study dissolution kinetics of amlodipine tablets in order to assess their equivalence under conditions in vitro according to the biowaiver. The study of dissolution kinetics of drugs in the form of amlodipine tablets has been carried out in accordance with the requirements of the “biowaiver” procedure, the recommendations of the SPhU and the WHO requirements in order to assess the possibility of replacing the pharmacokinetic studies in vivo by tests in vitro. The possibility to use the recommendations of the "biowaiver" procedure for the registration of generics amlodipine tablets has been found. The studies conducted have shown that amlodipine can be referred to class І of the biopharmaceutical classification system, i.e. substances with a high biopharmaceutical solubility and a high penetration rate. It will allow conducting comparative studies in vitro to confirm the equivalence of drugs. The evaluated amlodipine drugs fulfill biowaiver criteria for drugs containing BCS Class I active pharmaceutical ingredients. Both drugs are “rapidly dissolving,” both meet the criteria of dissolution profile similarity, f2 (i.e., the dissolution profile of the test product is similar to that of the reference product in pH 1.2, 4.5, and 6.8 buffers using the paddle method at 75 rpm), and both are considered to be in vitro equivalent without in vivo evaluation. The proposed chromatographic methods are simple, rapid and accurate for the determination of amlodipine in pharmaceutical dosage forms and can be used for routine quality control of drugs and in vitro dissolution study.

Sign in / Sign up

Export Citation Format

Share Document