Stability of Atropine in Aqueous Solution**Physiology Division, Directorate of Medical Research, Army Chemical Center, Md.

Kondritzer, Albert A.; Zvirblis, Peter

doi:10.1002/jps.3030460905

Cited by 18 publications

(7 citation statements)

References 4 publications

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“…19 Both formulations were stable through 180 days when refrigerated, but at room temperature, both formulations, though unopened, showed a steady reduction in concentration from 95% to 70% between 30 and 180 days. We are not able to clarify the apparent discrepancy between these studies 17,18 and older work, 14,16 although the most recent demonstrates that failure to account for pH can lead to instability at room temperature. 19 We are aware of several commercial firms developing lowconcentration atropine for chronic use in myopic children.…”

Section: Discussioncontrasting

confidence: 57%

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Compounding of Low-Concentration Atropine for Myopia Control

Richdale

Tomiyama

Novack

et al. 2022

Eye &Amp; Contact Lens: Science &Amp; Clinical Practice

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Objectives: Low-concentration atropine is commonly prescribed to slow myopia progression in children but is not Food and Drug Administration-approved for that indication and is only available in the United States from compounding pharmacies. The purpose of this study was to ascertain its reported compounding and labeling in the United States. Methods: US compounding pharmacies were identified through a survey of eye doctors, social media, conferences, and web search. Twenty-eight pharmacies were identified and contacted through telephone and asked a standard set of questions about their methods to compound and label lowconcentration atropine. Results: Twenty-six pharmacies across 19 states provided responses, with 21 answering all nine items (81%) and a mean of 8.7 of nine responses. The most frequently reported bottle size was 5 mL (interquartile range [IQR]: 3.5-10). For storage, 10 pharmacies (38%) recommended refrigeration and 16 (62%) stated room temperature was sufficient. The median beyond-use date provided was 65 days (IQR: 45-158). For preparation, 12 pharmacies (50%) used commercially available 1% solution, 9 (38%) used powdered atropine, 2 (8%) used both, and 1 (4%) stated their approach was proprietary. For the added excipients, 11 (42%) used artificial tears only, 6 (23%) added 0.9% saline only, 7 (27%) used more than one ingredient, and 2 (8%) were proprietary. Only two pharmacies mentioned adding boric acid and two mentioned "pH-adjusted" saline. Conclusions: There were a wide variety of formulation methods in the United States, which may affect atropine stability and potency. Similarly, there are a wide variety of storage and beyond-use recommendations. Further research is needed to assess how these variations may affect the efficacy and safety of low-concentration atropine and of myopia control.

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Section: Discussioncontrasting

confidence: 57%

“…The pH for maximum stability of atropine in sterile aqueous solution is 4.1 at 0°C and even lower at higher temperatures. 14 Although more alkaline formulations may sting less on insertion, they may be less stable.…”

mentioning

confidence: 99%

Compounding of Low-Concentration Atropine for Myopia Control

Richdale

Tomiyama

Novack

et al. 2022

Eye &Amp; Contact Lens: Science &Amp; Clinical Practice

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“…Invariably, activities are compared with partition coefficients obtained in some seemingly arbitrary partitioning system. Hansch and coworkers (3)(4)(5) were extremely successful in correlating a spectrum of biological response data with octanol-water partition coefficients. Beckett and Moffat (6) found that n-heptanewater partitioning gives excellent rank correlation with buccal absorption for several series of compounds.…”

Section: Acknowledgments and Addressesmentioning

confidence: 99%

Stability-Indicating Assay Methods for Drugs and Their Dosage Forms

Chafetz¹

1971

Journal of Pharmaceutical Sciences

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“…In this report, we follow the hydrolysis of procaine to give strongly fluorescent p -aminobenzoic acid in aqueous alkaline media, by recording fluorescence excitation−emission matrices as a function of reaction time, using a fast scanning detector, and processing the obtained four-way information with the classical PARAFAC model, as well as with the presently introduced multiway latent structured method N-PLS/RTL and some of its unfolded predecessors. We also compare the advantages and disadvantages of the above-mentioned chemometric techniques as regards the resolution of the presently studied multicomponent mixtures.…”

mentioning

confidence: 99%

“…Several analytical methods for the determination of either procaine or p-aminobenzoic acid in a variety of samples are known; [27][28][29][30][31][32][33][34][35] however, only few methods were developed for the simultaneous determination of both compounds, mainly based on highperformance liquid chromatographic techniques. [36][37][38] In this report, we follow the hydrolysis of procaine to give strongly fluorescent p-aminobenzoic acid in aqueous alkaline media, 39 by recording fluorescence excitation-emission matrices as a function of reaction time, using a fast scanning detector, and processing the obtained four-way information with the classical PARAFAC model, as well as with the presently introduced multiway latent structured method N-PLS/RTL and some of its unfolded predecessors. We also compare the advantages and disadvantages of the above-mentioned chemometric techniques as regards the resolution of the presently studied multicomponent mixtures.…”

mentioning

confidence: 99%

Multiway Partial Least-Squares Coupled to Residual Trilinearization: A Genuine Multidimensional Tool for the Study of Third-Order Data. Simultaneous Analysis of Procaine and Its Metabolite p-Aminobenzoic Acid in Equine Serum

et al. 2007

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A new third-order multivariate calibration approach, based on the combination of multiway-partial least-squares with a separate procedure called residual trilinearization (N-PLS/RTL), is presented and applied to multicomponent analysis using third-order data. The proposed chemometric algorithm is able to predict analyte concentrations in the presence of unexpected sample components, which require strict adherence to the second-order advantage. Results for the determination of procaine and its metabolite p-aminobenzoic acid in equine serum are discussed, based on kinetic fluorescence excitation-emission four-way measurements and application of the newly developed multiway methodology. Since the analytes are also the reagent and product of the hydrolysis reaction followed by fast-scanning fluorescence spectroscopy, the classical approach based on parallel factor analysis is challenged by strong linear dependencies and multilinearity losses. In comparison, N-PLS/RTL appears an appealing genuine multiway alternative that avoids the latter complications, yielding analytical results that are statistically comparable to those rendered by related unfolded algorithms, which are also able to process four-way data. Prediction was made on validation samples with a qualitative composition similar to the calibration set and also on test samples containing unexpected equine serum components.

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Stability of Atropine in Aqueous Solution**Physiology Division, Directorate of Medical Research, Army Chemical Center, Md.

Cited by 18 publications

References 4 publications

Compounding of Low-Concentration Atropine for Myopia Control

Compounding of Low-Concentration Atropine for Myopia Control

Stability-Indicating Assay Methods for Drugs and Their Dosage Forms

Multiway Partial Least-Squares Coupled to Residual Trilinearization: A Genuine Multidimensional Tool for the Study of Third-Order Data. Simultaneous Analysis of Procaine and Its Metabolite p-Aminobenzoic Acid in Equine Serum

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