In vitro release testing (IVRT) serves as a crucial tool to assess the quality, physicochemical behavior, and performance of semisolid formulations already available on market. skin permeation studies (IVPT) are widely used evaluate safety efficacy profiles topical drugs, utilizing biological membranes prepared from ex vivo human porcine tissues. This study aimed develop validate discriminative IVRT method various marketed benzoyl peroxide formulations. Additionally, IVPT was employed...

Different processing conditions to produce emulsions can modify the dispersion of ingredients, visual aspect, and viscosity, influencing final product’s effectiveness. In this study, a primary sunscreen emulsion was produced by conventional stirring process subsequently subjected separately complementary methods. A Box-Behnken 23 factorial design applied each method: High-Shear Method (CP-HS) High-Pressure Homogenization (CP-HPH). The present study aimed investigate influence these processes...

We evaluated the effects of incorporation zinc oxide (ZnO) nanoparticles in a mesoporous matrix, aiming to improve textural, structural and morphological properties verify their safety so that they can be applied sunscreen cosmetics.ZnO nano-particles were incorporated into an ordered silica matrix known as Santa Barbara Amorphous-15 (SBA-15), using post-synthesis methodology. The resulting nanocomposites characterized X-ray diffraction, small angle scattering, N2 adsorption-desorption...

A biowaiver is accepted by the Brazilian Health Surveillance Agency (ANVISA) for immediate-release solid oral products containing Biopharmaceutics Classification System (BCS) class I drugs showing rapid drug dissolution. This study aimed to simulate plasma concentrations of fluconazole capsules with different dissolution profiles and run population simulation evaluate their bioequivalence. The two batches reference product Zoltec® 150 mg capsules, A1 A2, other (B1 B2; C1 C2), as well...

<p>USP Apparatus 3 (reciprocating cylinder) is a very versatile device for the <italic>in vitro</italic> assessment of release characteristics solid oral dosage forms, because it enables product to be subjected different dissolution media and agitation speeds in single run. In this paper, brief history description system are presented, along with its applications development immediate modified products simulation fasted fed states using biorelevant media. Furthermore,...

Abstract A range of liquid emollient ester‐loaded body emulsions were evaluated on the basis sensory profile, consumer perception, physicochemical, biometrological, and rheological performances. This was complemented by skin hydration transepidermal water loss (TEWL) studies performed using a Corneometer® Tewameter®, respectively. The showed similar behavior creams variation shear stress, frequency, temperature. However, performances found varied when compared between base cream...

This study aimed to develop a biopredictive dissolution method for desvenlafaxine ER tablets using design of experiments (DoE) and physiologically based biopharmaceutics modeling (PBBM) address the challenge developing generic drug products by reducing risk product failure in pivotal bioequivalence studies. For this purpose, PBBM was developed GastroPlus® combined with Taguchi L9 design, evaluate impact different (Reference, Generic #1 #2) test conditions on release. The influence...

The solid dispersion approach is an alternative to increase drug solubility. Many carriers have been studied, but there few information about poloxamer 407 (P407). Consequently, the objective of this study was evaluate P407 as a carrier for nimodipine dispersions and compare its solubility dissolution rates with those from polyethylene glycol (PEG 6000). were prepared by hot melting solvent methods they characterized FTIR, DSC, solubility, tests. results indicated three-fold in presence than PEG.

The development of extended-release dosage forms with adequate drug release is a challenge for pharmaceutical companies, mainly when the presents high solubility, as in Biopharmaceutics Classification System (BCS) class I. This study aimed to develop mini-tablets containing metoprolol succinate (MS), while integrating design experiments (DOE) and physiologically based biopharmaceutics modeling (PBBM), predict its absorption run virtual bioequivalence (VBE) studies both fasted fed states....

The search for new pharmaceutical dosage forms and different drug delivery systems already used in therapeutics is a global trend, serving as an opportunity to expand the portfolio industry. In this context, multiparticulate systems, such pellets, granules, minitablets, represent attractive alternative, given range of possibilities they provide. Among methods production these we highlight process extrusion-spheronization pellet manufacture, wet granulation hot-melt extrusion obtention direct...

Intrinsic dissolution testing allows characterizing drug substances through its rate when exposed to a specified surface area in specific media.This can be used determine if substance is highly or poorly soluble.In this work, DDDPlus version 4.0 (Simulations Plus, Inc.) was simulate intrinsic experiments for pyrimethamine and metronidazole.These drugs have low high solubility properties.Predicted rates (IDR) were compared observed vitro IDR.Physicochemical parameters from literature the...

Hypochlorhydria is a condition where the production of hydrochloric acid in stomach decreased. As result, intragastric pH elevated. This can be due to series causes, such as disease (gastric mucosal infection caused by Helicobacter pylori and prominent AIDS patients), ethnicity, age also use antisecretory agents. may significantly impact absorption other drugs that have pH-dependent solubility, ketoconazole, weak base. Within this context, purpose study was demonstrate how GastroPlusTM –...

In this study, fluid bed granulation was applied to improve the dissolution of nimodipine and spironolactone, two very poorly water-soluble drugs. Granules were obtained with different amounts sodium dodecyl sulfate croscarmellose then compressed into tablets. The behavior tablets studied by comparing their profiles efficiency those from physical mixtures drug excipients subjected similar conditions. Statistical analysis results demonstrated that process improves both spironolactone addition...

Developing extended-release (ER) formulations with appropriate release characteristics can be challenging for formulation scientists.The aim of this study was to demonstrate the use computer-simulated dissolution profiles associated statistical experimental design in development doxazosin ER tablet formulations.Experimental tablets were prepared and tested using USP Apparatus 2 900 mL simulated gastric fluid without enzyme at 37 ± 0.5 °C 75 rpm 960 minutes.The results used optimize...

A tablet formulation based on hydrophilic matrix with a controlled drug release was developed, and the effect of polymer concentrations primaquine diphosphate evaluated. To achieve this purpose, 20-run, four-factor multiple constraints proportions components employed to obtain compositions. Drug determined by an in vitro dissolution study phosphate buffer solution at pH 6.8. The polynomial fitted functions described behavior mixture simplex coordinate systems effects each factor (polymer)...

Oseltamivir phosphate is used to treat influenza. For registration of a generic product, bioequivalence studies are crucial, however, in vitro can sometimes replace the conventional human pharmacokinetic. To assess whether dissolution profile comparable with vivo release, physiologically based pharmacokinetic absorption models (PBPK) being used. The aim study was develop capsule oseltamivir 30 mg process understanding and control, development PBPK model comparison virtual (VBE) real that...

Dissolution testing has emerged in the pharmaceutical field as a very important tool to characterise performance of drug products. Enrofloxacin is an antimicrobial frequently used veterinary medicine that no dissolution method described pharmacopoeias. In vitro tests enrofloxacin tablets were performed using different test parameters under ‘sink’ conditions. A two-factor three-level factorial design was obtained statistical software, on which nine runs performed. The independent variables...

In this study, orodispersible films formed from hydroxypropyl methylcellulose (HPMC) E6 (2, 2.5, and 3%) plasticizers ((glycerin (Gly), propylene glycol (PP), or polyethylene (PEG)), containing doxazosin mesylate, were prepared by the solvent casting method characterized. Design of experiments (DoE) was used as a statistical tool to facilitate interpretation experimental data allow identification optimal levels factors for maximum formulation performance. Differential scanning calorimetry...

The aim of this study was to use the physiologically based biopharmaceutics modeling (PBBM) strategy evaluate biopredictive power different dissolution test conditions for immediate release tablets containing 20 mg rivaroxaban. model developed and validated with literature data used predict plasma concentration-time curves reference drug product Xarelto® on experimental profiles. Virtual bioequivalence studies were run considering each profile under fasted fed method. profiles results...

Urea’s thermal instability and burning on sensitive skin can cause problems for cosmetic formulations. To overcome these drawbacks, urea was incorporated into ordered mesoporous silica (SBA-15). SBA-15 synthesized using tetraethyl orthosilicate Pluronic® P123 in an acid medium. Urea (20 wt.%) calcined by the incipient wetness impregnation method. Several techniques were used to characterize samples. Skin hydration transepidermal water loss measured Corneometer® CM 825 PC Tewameter® 300 TM....