Dissolution studies were performed with apparatus II (paddle) according to the USP specifications for ibuprofen tablets.10 The dissolution characteristics of at least 12 tablets of each batch were studied at pH 7.2 in phosphate buffer at 37°C ± 0.5°C. The dissolution tests were performed in an Erweka DT80 (Heusenstamm, Germany) at a rotating speed of 50 rpm. Samples (5 mL) were withdrawn at different sampling times (0, 5, 10, 15, 20, 30, 45 and 60 minutes) without reposition. Samples were filtered immediately after sampling with a 0.45 µm filter (hydrophilic PVDF Millex-HV, Millipore, Billerica, MA, USA). Ibuprofen was measured by UV spectrophotometry at 266 nm in a Beckman Coulter Du-6 spectrophotometer (Brea, CA, USA). The initial release rate was estimated as the ibuprofen (% of theoretical dose) released during the first 5 minutes (Q5). This parameter was used to compare differences on the release between the formulations.
Dt 80
Manufactured by Erweka
Sourced in Germany
The DT 80 is a disintegration tester manufactured by Erweka. It is designed to test the disintegration of pharmaceutical solid dosage forms such as tablets, capsules, and suppositories according to pharmacopoeial standards.
Automatically generated - may contain errors
6 protocols using dt 80
1
Ibuprofen Tablets Dissolution Analysis
2
Dissolution Testing of Pharmaceuticals
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All dissolution tests were performed using a calibrated USP II (paddle) apparatus (Erweka DT 80, Heusenstamm, Germany) at 37 ± 0.4 °C. Each vessel contained 500 mL of fresh, pre-warmed medium and the rotational speed was set at 75 rpm. Samples were withdrawn at 2.5, 5, 10, 15, 20, 30, 45, 60, 90, and 120 min via a 5 mL glass syringe connected to a stainless-steel cannula containing a 10 μm polyethylene cannula filter. Immediately thereafter, the sample was filtered through a 0.45 μm PTFE filter (ReZist 30, GE Healthcare UK Ltd., Buckinghamshire, United Kingdom), discarding the first 2 mL. The filtrate was immediately diluted with mobile phase and analyzed by HPLC-UV (see Section 2.5 ). The removal of 5 mL at each sampling time was considered in the calculation of the percentage dissolved. All experiments were performed at least in triplicate (n ≥ 3) and the final pH in the vessel was recorded.
3
Dissolution Profiling of Modified-Release Minitablets
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The dissolution tests were performed in triplicate to evaluate the modified release profile of minitablets using a United States Pharmacopoeia (USP) apparatus 2 (ERWEKA DT 80, Heusenstamm, Germany). A stirring speed of 100 rpm was utilised to investigate the drug release profile under stressed conditions [15 ]. The employed dissolution media were USP simulated gastric fluid (SGF) without enzymes (pH 1.2) containing 2 g of sodium chloride (NaCl), and 7 mL of hydrochloric acid (HCl, 37%) per litre of deionised water with 0.5% sodium lauryl sulfate for the first two hours, followed by USP simulated intestinal fluid (SIF) without enzymes (pH 6.8) prepared using 6.8 g of monobasic potassium phosphate (KH2PO4) and 0.62 g of sodium hydroxide (NaOH) per litre of deionised water with 0.5% sodium lauryl sulfate, as described in the USP [16 ]. SGF (250 mL) was used during the first 2 h. SIF (250 mL) was added and dissolution continued for 22 h at 37 ± 0.5 °C. NaOH (10 M) was used to adjust the pH to 6.8 after the addition of the SIF. Samples (2 mL) were withdrawn from the dissolution media and filtered through a hydrophilic 0.45 μm filter (Millipore, Millex-LCR, Merck, Madrid, Spain) at 5, 10, 15, 30 and 45 min, 1, 1.5, 2, 3, 4, 6, 8, and 24 h. As a comparison, two commercially available tablets of NFD were also tested, Adalat Oros® 30 mg and Adalat Retard® (20 mg).
4
Dissolution Testing of 3D-Printed Tablets
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Dissolution tests were carried out on all types of 3DP tablets (NFD-loaded HS, NFD-loaded PVA and NFD-loaded PVA and HS combined tablets) and Adalat Oros 30 mg modified release tablets, using a type dissolution II apparatus (rotating paddle, at 100 rpm) with six glass 900 mL vessels (DT-80, Erweka, Germany) at 37 °C. Simulated gastric fluid (SGF) with no pepsin (pH 1.2 ± 0.1, 500 mL) and 0.5% w/v sodium lauryl sulphate was utilised for the first 2 h followed by the addition of 400 mL of simulated intestinal medium (with no enzymes, pH adjusted to 6.8 ± 0.1 with 7 mL of NaOH 30% w/v) also containing 0.5% w/v of sodium lauryl sulphate, after which time dissolution testing was continued for a further 22 h, as described in the USP [33 ,34 ]. Samples (2 mL) were collected at various time intervals (5, 10, 15, 20, 30 min and at 1, 2, 3, 4, 6, and 24 h), filtered (hydrophilic PTFE 0.45 μm syringe filter, Millipore, Millex-LCR, Madrid, Spain) and diluted (1:3 v/v) with mobile phase prior to HPLC analysis.
5
Chloroquine Dissolution Kinetics in Distilled Water
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Dissolution test was carried out according to United States Pharmacopoeia (USP) XXIII basket method with an eight-chambered dissolution test machine (Erweka Germany Type: DT 80) operated at 100 rpm for 45 min in 900 mL of distilled water, maintained at 37 ± 0.5°C. Five milliliters (5 mL) of dissolution fluid was withdrawn and replaced with 5 mL of fresh medium at the following intervals: 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min, and 45 min. Each withdrawn sample was made up to 20 mL with fresh medium, filtered, and its absorbance determined with ultraviolet (UV)-visible spectrophotometer (UV - 160A, Shimadzu Corporation, Japan) at 323 nm and distilled water as blank. Triplicate determinations were conducted and the mean values used to evaluate the percentage drug released using the Beer's plot for chloroquine (y = 0.0365x - 0.0034, R2 = 0.9934) and applying the appropriate dilution factor.
6
Biorelevant Dissolution of Zolpidem Tablets
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Although as a BCS Class I drug, compendial media would be appropriate for studying dissolution of zolpidem in the fasted state, to simulate the food effect in vitro it is necessary to use biorelevant media (Markopoulos et al., 2015) . Data for biorelevant dissolution simulating the fasted and fed states were taken from a previous publication by Paraiso and co-workers (2019) (Paraiso et al., 2019) . The data were digitized using the software WebPlotDigitizer v. 4.2 (San Francisco, USA; source: https://automeris.io/WebPlotDigitizer). The composition of the biorelevant media used to simulate the fed state is summarized in Table 1. The biorelevant dissolution tests were performed using USP 2 dissolution test apparatus (Erweka DT 80, Heusenstamm, Germany) at 37 ± 0.5 o C in 500 mL medium. The dissolution behavior of Stilnox® tablets was investigated at 50 rpm in 500 mL of FeSSGF middle Level II, . FeSSGF middle (pH 5.0 and 1.75% fat) is the biorelevant media that represents the period from 75-165 minutes after food ingestion. This medium was selected because in the clinical study, Stilnox® tablets were ingested after a low fat breakfast (Greenblatt et al., 2006) . Sampling for all dissolution tests was performed at 5, 10, 20, 30, 40, 50, 60 and 120 minutes.
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