Reverse engineering and formulation by QBD of olopatadine hydrochloride ophthalmic solution

Ahmed, Zahid Zaheer; Khan, Furquan Nazimuddin; Shaikh, Darakhshan Afreen

doi:10.1007/s40005-017-0312-1

Cited by 12 publications

(6 citation statements)

References 2 publications

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“…The DSC thermograms of olopatadine HCl, ethyl cellulose (10 cp), and microparticles (MP-1:1, MP-1:2, and MP-1:3) are shown in Supplementary Material (Part F). Olopatadine HCl showed characteristic single sharp endothermic peak at 253.9 C [enthalpy of fusion 125.08 J/g], corresponding to its melting point 59 and crystalline nature. There was a noticeable reduction and broadening in the endothermic peaks of olopatadine HCleloaded ethyl cellulose microparticles as compared to olopatadine HCl.…”

Section: Differential Scanning Calorimetry (Dsc)mentioning

confidence: 99%

Novel Polyvinyl Pyrrolidone–Loaded Olopatadine HCl–Laden Doughnut Contact Lens to Treat Allergic Conjunctivitis

Xue

Zhang²,

Yan³

et al. 2020

Journal of Pharmaceutical Sciences

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Section: Differential Scanning Calorimetry (Dsc)mentioning

confidence: 99%

Novel Polyvinyl Pyrrolidone–Loaded Olopatadine HCl–Laden Doughnut Contact Lens to Treat Allergic Conjunctivitis

Xue

Zhang²,

Yan³

et al. 2020

Journal of Pharmaceutical Sciences

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“…As shown in Figure 5, probability maps were drawn using MODDE software, based on the calculated model of particle size and zeta potential and the Monte Carlo simulation for RA [37]. Monte Carlo simulations were performed for error propagation for the function relating the independent variables to the dependent variables, giving distributions of dependent variables (i.e., resolutions) for each operating condition of the response surface methodology [38][39][40]. The design space established by the Monte Carlo simulation is expected to be considerably smaller than that of the overlay plot.…”

Section: Establishment Of the Design Spacementioning

confidence: 99%

Development of a Resveratrol Nanosuspension Using the Antisolvent Precipitation Method without Solvent Removal, Based on a Quality by Design (QbD) Approach

Kuk

et al. 2019

Pharmaceutics

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The purpose of this study was to develop a resveratrol nanosuspension with enhanced oral bioavailability, based on an understanding of the formulation and process parameters of nanosuspensions and using a quality by design (QbD) approach. Particularly, the antisolvent method, which requires no solvent removal and no heating, is newly applied to prepare resveratrol nanosuspension. To ensure the quality of the resveratrol nanosuspensions, a quality target product profile (QTPP) was defined. The particle size (z-average, d90), zeta potential, and drug content parameters affecting the QTPP were selected as critical quality attributes (CQAs). The optimum composition obtained using a 3-factor, 3-level Box–Behnken design was as follows: polyvinylpyrrolidone vinyl acetate (10 mg/mL), polyvinylpyrrolidone K12 (5 mg/mL), sodium lauryl sulfate (1 mg/mL), and diethylene glycol monoethyl ether (DEGEE, 5% v/v) at a resveratrol concentration of 5 mg/mL. The initial particle size (z-average) was 46.3 nm and the zeta potential was −38.02 mV. The robustness of the antisolvent process using the optimized composition conditions was ensured by a full factorial design. The dissolution rate of the optimized resveratrol nanosuspension was significantly greater than that of the resveratrol raw material. An in vivo pharmacokinetic study in rats showed that the area under the plasma concentration versus time curve (AUC0–12h) and the maximum plasma concentration (Cmax) respectively, than those of the resveratrol raw material. Therefore, the prepara values of the resveratrol nanosuspension were approximately 1.6- and 5.7-fold higher,tion of a resveratrol nanosuspension using the QbD approach may be an effective strategy for the development of a new dosage form of resveratrol, with enhanced oral bioavailability.

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“…The current procedure will help make the generic formulation. Ahmed et al 1 did the reverse engineering study for OPT nasal spray 0.1% only by utilizing the different solubility techniques, but the proposed article clearly stated that the research was done at the academic level. The methods used for the study had a sensitivity issue.…”

Section: Introductionmentioning

confidence: 99%

Regulatory Perspective Reverse Engineering Analysis of the Mast Cell Stabilizer and the Histamine Receptor Antagonist (Olopatadine HCl): Instrumental and Classical Methods for Multiple Formulations

Kowtharapu

Katari

Sandoval³

et al. 2023

ACS Omega

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This study evaluates the unknown qualitative (Q1) and quantitative (Q2) formulas for nasal spray and ophthalmic solution formulations of olopatadine HCl by classical and instrumental techniques to match the generic formula with reference-listed drugs to avoid clinical study. Reverse engineering of olopatadine HCl nasal spray 0.6% and ophthalmic solution 0.1, 0.2% formulations was accurately quantified using a simple and sensitive reversed-phase high-performance liquid chromatography (HPLC) method. Both formulations possess similar components, namely ethylenediaminetetraacetic acid (EDTA), benzalkonium chloride (BKC), sodium chloride (NaCl), and dibasic sodium phosphate (DSP). These components were qualitatively and quantitatively determined using the HPLC, osmometry, and titration techniques. With derivatization techniques, EDTA, BKC, and DSP were determined by ion-interaction chromatography. NaCl in the formulation was quantified by measuring the osmolality and using the subtraction method. A titration method was also used. All the employed methods were linear, accurate, precise, and specific. The correlation coefficient was >0.999 for all components in all the methods. The recovery results ranged from 99.1 to 99.7% for EDTA, 99.1−99.4% for BKC, 99.8−100.8% for DSP, and 99.7−100.1% for NaCl. The obtained % relative standard deviation for precision was 0.9% for EDTA, 0.6% for BKC, 0.9% for DSP, and 1.34% for NaCl. The specificity of the methods in the presence of other components, diluent, and the mobile phase was confirmed, and the analytes were specific.

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Reverse engineering and formulation by QBD of olopatadine hydrochloride ophthalmic solution

Cited by 12 publications

References 2 publications

Novel Polyvinyl Pyrrolidone–Loaded Olopatadine HCl–Laden Doughnut Contact Lens to Treat Allergic Conjunctivitis

Novel Polyvinyl Pyrrolidone–Loaded Olopatadine HCl–Laden Doughnut Contact Lens to Treat Allergic Conjunctivitis

Development of a Resveratrol Nanosuspension Using the Antisolvent Precipitation Method without Solvent Removal, Based on a Quality by Design (QbD) Approach

Regulatory Perspective Reverse Engineering Analysis of the Mast Cell Stabilizer and the Histamine Receptor Antagonist (Olopatadine HCl): Instrumental and Classical Methods for Multiple Formulations

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