scholarly journals In-Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South Weast Ethiopia

2020 ◽  
Author(s):  
Woldemichael Abraham Leficho ◽  
Habtamu Abuye Lambore ◽  
Selass Kebede Olbemo ◽  
Sultan Suleman Wega
Keyword(s):  
Single Point ◽  
Essential Medicines ◽  
In Vitro Dissolution ◽  
Ratio Test ◽  
Doxycycline Hyclate ◽  
Dissolution Tests ◽  
Post Market ◽  
Access To Essential Medicines ◽  
Equivalence Problems

Persistent post market quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces biopharmaceutically and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high cost barrier imposed by few expensive brands of the product. This study was aimed at determining the quality and evaluating equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Ten brands of doxycycline hyclate capsules and tablets were tested for physic-chemical parameters. All investigated brands of doxycycline complied with the USP for dosage unifor¬mity, assay of active ingredient and single-point dissolution tests. One brand, D09 failed both hardness and friabilty tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06 and D07 had similarity with innovator. Ratio test approaches also showed significant variability existence between test products and comparators. This may question the product’s being categorized as a <biowaiver> to mean in-vitro dissolution evaluation suffices its market approval. This work, however, found equivalence problems between ‘comparators’ and interchangeability issues among doxycycline different brands already distributed in the market.

scholarly journals In Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South-West Ethiopia

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Woldemichael Abraham ◽  
Habtamu Abuye ◽  
Selass Kebede ◽  
Sultan Suleman
Keyword(s):  
Quality Assessment ◽  
Single Point ◽  
Dosage Forms ◽  
Essential Medicines ◽  
In Vitro Dissolution ◽  
Ratio Test ◽  
Doxycycline Hyclate ◽  
Product Identity ◽  
Dosage Uniformity

Background. Persistent postmarket quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces a biopharmaceutical and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high-cost barrier imposed by a few expensive brands of the product. This study was aimed at determining the quality and evaluating the equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Methods. Ten brands of doxycycline hyclate capsules and tablets were tested for product identity, dosage uniformity, assay, and in vitro dissolution; and tablets were tested for friability and hardness. Results. All investigated brands of doxycycline complied with the USP for dosage uniformity, an assay of the active ingredient, and single-point dissolution tests. One brand, D09, failed both hardness and friability tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06, and D07 had similarities with the innovator. Ratio test approaches also showed that significant variability exists between test products and comparators. Weibull model was found to provide the best adjustment curve for all brands, from model-dependent approaches employed for explaining the overall release of drug from the dosage forms. Conclusions. Doxycycline is a biowaiver product. Hence, in vitro dissolution evaluation suffices its market approval. In this quality assessment study, however, the samples passed quality control tests, except D09 brand which failed friability; it has been revealed that five out of eight brands had problems with interchangeability. Only three doxycycline hyclate brands were found to be equivalent to the comparators.

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.

Sign in / Sign up

Export Citation Format

Share Document