Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method

Martins, Magda Targa; Paim, Clésio Soldateli; Steppe, Martin

doi:10.1590/s1984-82502010000200003

Cited by 11 publications

(8 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The initial dissolution profiles revealed that coamorphization caused a pronounced increase in the dissolution rate in all of the systems. The concentration in solution appeared to level off; i.e., the systems attained equilibrium, in about 2 h. The aqueous solubility of the crystalline LAM, in phosphate buffered saline (pH 6.8; 37 °C), was reported to be ∼394 and 382 μg/mL. , This is in excellent agreement with the “equilibrium” concentration (Figure a). In the coamorphous system, the concentration in solution was approximately doubled.…”

Section: Resultssupporting

confidence: 66%

Dual Functionality of Bile Acid: Physical Stabilization of Drugs in the Amorphous Form and Solubility Enhancement in Solution

et al. 2022

View full text Add to dashboard Cite

Drugs containing an amino aromatic nitrogen moiety were stabilized in the amorphous form by the surfactant cholic acid (CA). Coamorphous systems of lamotrigine (LAM), pyrimethamine (PYR), and trimethoprim (TRI) were each prepared with CA. Drug–CA interactions, investigated by IR and solid-sate NMR spectroscopy, revealed deprotonation of the carboxylic acid group in CA and the protonation of the most basic nitrogen of the drug. The coamorphous systems exhibited exceptional physical stability and resisted crystallization at (i) elevated temperatures (>100 °C) and (ii) accelerated storage conditions, 40 °C/75% relative humidity for 15 months. The dissolution performance of each coamorphous system was compared with the respective crystalline drug based on the area under the curve (AUC) of the concentration–time profiles. A 25-fold increase in AUC was observed in the PYR–CA coamorphous system. The solubility enhancement is attributed not only due to drug amorphization but also due to solubilization by CA. The supramolecular synthon approach, through a drug–CA interaction, yielded physically stable coamorphous systems with enhanced aqueous drug solubility.

show abstract

Section: Resultssupporting

confidence: 66%

Dual Functionality of Bile Acid: Physical Stabilization of Drugs in the Amorphous Form and Solubility Enhancement in Solution

et al. 2022

View full text Add to dashboard Cite

show abstract

“…The content of LMT in tablets and in dissolution samples was determined by measuring the absorbance using UV/Vis spectrophotometric method, which was previously published and confirmed [ 19 , 20 ]. The absorbance of LMT was measured at a wavelength of 267 nm in pH 1.2 dissolution medium [ 19 ] and 304 nm in pH 6.8 dissolution medium [ 20 ].…”

Section: Methodsmentioning

confidence: 85%

The Effect of Humidity on the Dissolution Kinetics and Tablet Properties of Immediate-Release Tablet Formulation Containing Lamotrigine

et al. 2022

View full text Add to dashboard Cite

This study aims to find the effects of high (75%) and low (30%) humidity conditions and its correlation with formulation composition on dissolution kinetics of lamotrigine (LMT) from prepared immediate-release tablets during one- and four-week periods. Two types of fillers microcrystalline cellulose (MCC) or anhydrous lactose (LAC), disintegrant sodium starch glycolate (NaSG, 0.5% or 4%), and lubricant magnesium stearate (MgST, 0.25% or 5%) were used. A three-factor two-stage complete factorial design (2³) was used to assess the influence of the composition of the tested formulations. The tablets were produced by direct compression and characterized using a disintegration test, a resistance to crushing test, and dissolution tests (pH 1.2 and pH 6.8). Using Design Expert software, it was concluded that in addition to the effect of fillers on pH 6.8, NaSG has a significant impact after exposure to high and low humidity, as well as its interaction with LAC and MCC. In the dissolution medium pH 1.2, under conditions of high humidity, the content of MgST and NaSG and their interaction show a significant influence. The release rate of LMT was affected by humidity as well as type of excipients and their interactions.

show abstract

“…Any change requires an evaluation of the method's performance. The validation of the method, comparative tests with standard methods, and co-validation between laboratories are the possible strategies to achieve this goal [18]. In this case, the method was validated in terms of the linearity, precision, repeatability, measurement of uncertainty, and accuracy.…”

Section: Discussionmentioning

confidence: 99%

Validation of Rapid Enzymatic Quantification of Acetic Acid in Vinegar on Automated Spectrophotometric System

Dini

Lorenzo

Senatore³

et al. 2020

Foods

View full text Add to dashboard Cite

Vinegar is produced from the fermentation of agricultural materials and diluted acetic acid (diluted with water to 4–30% by volume) via sequential ethanol and acetic acid fermentation. The concentration of acetic acid must be measured during vinegar production. A Community method for analyzing acetic acid in vinegar is a non-specific method based on the assumption that the total acid concentration of the vinegar is attributable to the acetic acid. It consists of titration with a strong base in the presence of an indicator. This test is laborious and has a time-consuming character. In this work, a highly specific automated enzymatic method was validated, for the first time, to quantify the acetic acid in the wine vinegar, in terms of linearity, precision, repeatability, and uncertainty measurement. The results were compared to the Community method of analysis. Regression coefficient ≅ 1 and the normal distribution of residuals in the ANOVA test confirmed the method’s linearity. LLOD (0.946 ppm) and LLOQ (2.00 ppm) defined the method’s sensitivity. The results of the tested and the Community methods, linearly distributed in the Shapiro–Wilk test, confirmed the method’s repeatability. The few anomalous data in the Huber test were due to random errors. The high selectivity of the enzymatic method, which exclusively measures acetic acid concentration, determined the significant differences between the two tests, examined in the accuracy determination. The enzymatic method can be considered applicable since its precision and uncertainty were lower than the Community method values (relative percentage deviations = 10%). The enzymatic method compared to the Community method reduces the analysis time and the risk of errors due to operators (avoid pipetting errors and wrong calculations), minimizes solvent and the sample consumption and guarantees assay quality through method standardization.

show abstract

Development of a dissolution test for lamotrigine in tablet form using an ultraviolet method

Cited by 11 publications

References 22 publications

Dual Functionality of Bile Acid: Physical Stabilization of Drugs in the Amorphous Form and Solubility Enhancement in Solution

Dual Functionality of Bile Acid: Physical Stabilization of Drugs in the Amorphous Form and Solubility Enhancement in Solution

The Effect of Humidity on the Dissolution Kinetics and Tablet Properties of Immediate-Release Tablet Formulation Containing Lamotrigine

Validation of Rapid Enzymatic Quantification of Acetic Acid in Vinegar on Automated Spectrophotometric System

Contact Info

Product

Resources

About