Sources of variation during collaborative evaluation of in vitro dissolution tests for two solid preparations

1979 ◽  
Vol 31 (1) ◽  
pp. 434-440 ◽  
Author(s):  
A. C. CARTWRIGHT
Keyword(s):  
In Vitro Dissolution ◽  
Dissolution Tests ◽  
Sources Of Variation ◽  
Collaborative Evaluation

scholarly journals Automation of dissolution tests

2003 ◽  
Vol 25 (1) ◽  
pp. 7-15 ◽  
Author(s):  
Rolf Rolli
Keyword(s):  
Quality Control ◽  
In Vitro Dissolution ◽  
Pharmaceutical Companies ◽  
Dissolution Testing ◽  
Simultaneous Operation ◽  
Task Forces ◽  
The Core ◽  
Dissolution Tests ◽  
The 1960S

Dissolution testing of drug formulations was introduced in the 1960s and accepted by health regulatory authorities in the 1970s. Since then, the importance of dissolution has grown rapidly as have the number of tests and demands in quality-control laboratories. Recent research works lead to the development of in-vitro dissolution tests as replacements for human and animal bioequivalence studies. For many years, a lot of time and effort has been invested in automation of dissolution tests. There have been a number of in-house solutions from pharmaceutical companies and many have created task forces or even departments to develop automation. Robotic solutions with sequential operation were introduced as well as the simultaneous operation concept developed by SOTAX. Today, pharmaceutical companies focus their resources mainly on the core business and in-house engineering solutions that are very difficult to justify. Therefore, it is important to know the basic considerations in order to plan an automation concept and implement it together with a vendor.

scholarly journals Development and Validation of an Eco-friendly HPLC-UV-DAD Method for the Determination of Allopurinol in Pharmaceuticals with Application to In vitro Dissolution Studies

2021 ◽  
Vol 11 (5) ◽  
pp. 13089-13101
Keyword(s):  
Factorial Design ◽  
Matrix Effects ◽  
Dissolution Kinetics ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Dissolution Studies ◽  
Dissolution Tests ◽  
Development And Validation

In this study, a sustainable HPLC-UV-DAD method was developed and validated for the determination of allopurinol in tablets and optimization of the dissolution test using factorial design. The separation of the analyte from the sample matrix was achieved in 3.01 minutes in a C8 column (4.6 mm X 150 mm X 5 μm), using mobile phase 0.1 mol L-1 HCl (25%) + ethanol (50%) + ultrapure water (25%) by UV detection at 249 nm. The method presented satisfactory analytical parameters of validation (specificity, selectivity, linearity, stability, precision, accuracy, and robustness), showing no matrix effects. The dissolution test was optimized by complete factorial design 23 and, the optimal conditions were: HCl 0.001 mol L-1, apparatus II (paddle) and 75 rpm. The analytical procedures and dissolution tests were applied to allopurinol tablets marketed in Bahia, Brazil, to evaluate the dissolution studies. The pharmaceuticals had similar dissolution profiles and first-order dissolution kinetics. This new and sustainable HPLC-UV-DAD method is friendly to the environment and can be used for the routine pharmaceutical analysis of allopurinol in fixed dosage forms.

Decomposition of Microcystin-LR, Microcystin-RR, and Microcystin-YR in Water Samples Submitted to in Vitro Dissolution Tests

2004 ◽  
Vol 52 (19) ◽  
pp. 5933-5938 ◽  
Author(s):  
Isabel M. Moreno ◽  
Judith Maraver ◽  
Esther C. Aguete ◽  
Manel Leao ◽  
Ana Gago-Martínez ◽  
...  
Keyword(s):  
Water Samples ◽  
In Vitro Dissolution ◽  
Dissolution Tests

scholarly journals Formulation Development and Evaluation of Fast Dissolving Oral Film of Midodrine Hydrochloride

2020 ◽  
Vol 10 (3-s) ◽  
pp. 107-110
Author(s):  
Aashish Marskole ◽  
Sailesh Kumar Ghatuary ◽  
Abhishek Parwari ◽  
Geeta Parkhe
Keyword(s):  
Systemic Circulation ◽  
In Vitro Dissolution ◽  
Systemic Availability ◽  
Solvent Casting ◽  
Formulation Development ◽  
Casting Method ◽  
Onset Of Action ◽  
Disintegration Time ◽  
Dissolution Tests

Oral fast dissolving midodrine hydrochloride films prepared by solvent casting method, PEG 400 was the selected plasticizers, incorporating superdisintegrants such as croscarmellose sodium (CCS) and sodium starch glycolate (SSG) to achieve the goal. Drug content, weight variability, film thickness, disintegration time, endurance, percentage of moisture content, and in vitro dissolution tests were analyzed for the prepared films. In all formulations, the tensile strength value was found from 0.965±0.045 and 1.256±0.032 and the folding capacity was over 100. The assay values ranged from 97.98±0.25 to 99.89±0.36 percent for all formulations. The disintegration time was ranging between 55±9 to 120±6 sec, the minimum time for disintegration was found in formulation F5 (55±9). The prepared F5 formulation shows greater release of the drug (99.25±0.41 percent) within 15 min relative to other formulations. As the drug having low solubility, fast disintegration may leads to more drug availability for dissolution, resulting in faster absorption in systemic circulation increased systemic availability of drug leads to quick onset of action which is prerequisite for hypertension. Keywords: Midodrine hydrochloride, Fast dissolving films, Solvent casting method, Superdisintegrants.

scholarly journals The Relationships between Process Parameters and Polymeric Nanofibers Fabricated Using a Modified Coaxial Electrospinning

Nanomaterials ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. 843 ◽  
Author(s):  
Honglei Zhou ◽  
Zhaorong Shi ◽  
Xi Wan ◽  
Hualing Fang ◽  
Deng-Guang Yu ◽  
...  
Keyword(s):  
Process Parameters ◽  
Hydroxypropyl Methylcellulose ◽  
Taylor Cone ◽  
Electrostatic Energy ◽  
In Vitro Dissolution ◽  
Process Conditions ◽  
Sheath Fluid ◽  
Dissolution Tests ◽  
Important Challenge

The concrete relationship between the process parameters and nanoproduct properties is an important challenge for applying nanotechnology to produce functional nanomaterials. In this study, the relationships between series of process parameters and the medicated nanofibers’ diameter were investigated. With an electrospinnable solution of hydroxypropyl methylcellulose (HPMC) and ketoprofen as the core fluid, four kinds of nanofibers were prepared with ethanol as a sheath fluid and under the variable applied voltages. Based on these nanofibers, a series of relationships between the process parameters and the nanofibers’ diameters (D) were disclosed, such as with the height of the Taylor cone (H, D = 125 + 363H), with the angle of the Taylor cone (α, D = 1576 − 19α), with the length of the straight fluid jet (L, D = 285 + 209L), and with the spreading angle of the instable region (θ, D = 2342 − 43θ). In vitro dissolution tests verified that the smaller the diameters, the faster ketoprofen (KET) was released from the HPMC nanofibers. These concrete process-property relationships should provide a way to achieve new knowledge about the electrostatic energy-fluid interactions, and to meanwhile improve researchers’ capability to optimize the coaxial process conditions to achieve the desired nanoproducts.

Use of a Round-Bottom Resin Kettle for in vitro Dissolution Testing

1976 ◽  
Vol 59 (2) ◽  
pp. 367-367
Author(s):  
Ross D Kirchhoefer
Keyword(s):  
In Vitro Dissolution ◽  
Dissolution Testing ◽  
Drug Bioavailability ◽  
Dissolution Properties ◽  
Dissolution Tests

Abstract Dissolution tests are used to assist in the evaluation of drug bioavailability. A piece of glassware has been designed which allows one to take advantage of the dissolution properties of a 3-neck round-bottom flask and is compatible with and easier to use than existing stirring and bath equipment.

DEVELOPMENT AND EVALUATION OF A NOVEL TIME AND PH-DEPENDENT COLON TARGETED DRUG DELIVERY OF ORNIDAZOLE

2021 ◽  
pp. 108-111
Author(s):  
SUSHMA M ◽  
PAVANI S
Keyword(s):  
Drug Delivery ◽  
Drug Release ◽  
In Vitro Dissolution ◽  
Polymeric Coating ◽  
Delivery Method ◽  
Bulk Forming ◽  
Dissolution Tests ◽  
Inflammatory Bowel ◽  
Upper Gastrointestinal

Objective: The anti-amoebic drug Ornidazole was developed in this study as a novel colon-specific drug delivery method for the treatment of colonic diseases such as diverticulitis, inflammatory bowel syndrome, and Crohn’s disease. Pectin forms a matrix with a pH-sensitive polymeric coating that prevents drug release in the upper gastrointestinal tract, thereby addressing solubility issues. Pectin is sometimes used as an adsorbent, bulk-forming agent. Methods: Ornidazole-containing core tablets were directly compressed. Ornidazole compression coated tablets were formulated with varying polymer proportions in the coat. All the tablets were studied for weight uniformity, hardness, friability, drug content, and in vitro dissolution tests Results: All formulations demonstrated good Fourier-transform infrared compliance and no interaction between drug, polymer, and other excipients. The study’s findings show that the formulation F6 coated with Eudragit RS 100 had a drug release of 99.230.8 for 24 h. Conclusion: As a result, (F6) is regarded as the optimal formulation. The pH in the colon causes the release of Ornidazole from tablets.

scholarly journals Ampholytic and Polyelectrolytic Starch as Matrices for Controlled Drug Delivery

Pharmaceutics ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 253 ◽  
Author(s):  
Nassim Benyerbah ◽  
Pompilia Ispas-Szabo ◽  
Khalil Sakeer ◽  
Daniel Chapdelaine ◽  
Mircea Alexandru Mateescu
Keyword(s):  
Electrostatic Interactions ◽  
Drug Loading ◽  
Aqueous Media ◽  
In Vitro Dissolution ◽  
Polymeric Chain ◽  
Self Assembling ◽  
Dissolution Tests ◽  
One Step ◽  
Anionic Groups

The potential of the polyampholytic and polyelectrolytic starch compounds as excipients for drug controlled release was investigated using various tracers differing in terms of solubility and permeability. Ampholytic trimethylaminecarboxymethylstarch (TMACMS) simultaneously carrying trimethylaminehydroxypropyl (TMA) cationic groups and carboxymethyl (CM) anionic groups was obtained in one-step synthesis in aqueous media. Trimethylaminestarch (TMAS) and carboxymethylstarch (CMS) powders were also synthesized separately and then homogenized at equal proportions in liquid phase for co-processing by spray drying (SD) to obtain polyelectrolytic complexes TMAS-CMS (SD). Similarly, equal amounts of TMAS and CMS powders were dry mixed (DM) to obtain TMAS:CMS (DM). Monolithic tablets were obtained by direct compression of excipient/API mixes with 60% or 80% drug loads. The in vitro dissolution tests showed that ampholytic (TMACMS) and co-processed TMAS-CMS (SD) with selected tracers (one from each class of Biopharmaceutical Classification System (BCS)), were able to control the release even at very high loading (80%). The presence of opposite charges located at adequate distances may impact the polymeric chain organisation, their self-assembling, and implicitly the control of drug release. In conclusion, irrespective of preparation procedure, ampholytic and polyelectrolytic starch materials exhibited similar behaviours. Electrostatic interactions generated polymeric matrices conferring good mechanical features of tablets even at high drug loading.

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