The most appropriate storage method in unit-dose package and correlation between color change and decomposition rate of aspirin tablets

Yamazaki, Noriko; Taya, Kumiko; Shimokawa, Ken‐ichi; Ishii, Fumiyoshi

doi:10.1016/j.ijpharm.2010.06.031

Cited by 18 publications

(19 citation statements)

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“…Badaniom stabilności poddawane są także przepakowane leki w postaci syropów. Autorzy publikacji wykazują, że przepakowanie leków w systemie unit dose nie wpływa na ich stabilność [1,11,60,61,62]. Amerykańska Agencja ds.…”

Section: Funkcjonowanie Automatycznych Systemów Dystrybucji Leków W Punclassified

Automatic drug distribution systems (unit dose) in hospitals in Poland and in selected countries in the world

Stępniak

Bialik

Żuk

2017

Ann. Acad. Med. Siles.

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Implementowanie automatycznych i informatycznych technologii w medycynie i farmacji może zredukować liczbę błędów medycznych. Nowoczesnymi technologiami, pozwalającym ich uniknąć, są system automatycznego dozowania leków unit dose, wprowadzenie elektronicznych zleceń lekarskich, a także system kodów kreskowych, umożliwia-jący zidentyfikowanie pojedynczej dawki leku i pacjenta. Błędy w farmakoterapii są niebezpieczne dla życia i zdrowia pacjentów. W Polsce wciąż dominuje system dystrybucji leków, w którym apteka szpitalna realizuje zamówienia na leki dla oddziału szpitalnego, a nie dla indywidualnego pacjenta. System ten jest mało bezpieczny i stwarza ryzyko generowania błędów podczas podawania leków, dokumentowania ordynacji lekarskich oraz oceny procesu farmakoterapii, szczególnie pod względem finansowym. Od kilku lat w szpitalach w Polsce wprowadza się system dystrybucji leków unit dose, który umożliwia tworzenie elektronicznych zleceń lekarskich oraz ich kontrolę przez farmaceutę w aptece szpitalnej pod względem występowania interakcji między lekami i zachowania właściwego schematu dawkowania, jak ma to miejsce w szpitalach na świecie, gdzie od dawna stosowane są takie systemy dystrybucji. Sposób dystrybucji leków jest ważnym elementem, potrzebnym do zapewnienia sprawnego funkcjonowania szpitala. System unit dose zwiększa bezpieczeństwo farmakoterapii i zmniejsza koszty leczenia. Umożliwia również farmaceutom klinicznym pracującym w aptekach szpitalnych bezpośredni wpływ na stosowaną farmakoterapię i pracę na oddziale szpitalnym. System dystrybucji leków unit dose to przyszłość polskiej i światowej farmacji szpitalnej. S Ł O W A K L U C Z O W Eunit dose, system dystrybucji leków, apteka szpitalna

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Section: Funkcjonowanie Automatycznych Systemów Dystrybucji Leków W Punclassified

Automatic drug distribution systems (unit dose) in hospitals in Poland and in selected countries in the world

Stępniak

Bialik

Żuk

2017

Ann. Acad. Med. Siles.

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“…Volume was calculated by dividing this mass by the true density of hydromagnesite (2.2 g/ mL 11,12) ). [4] The mass of the residual unreacted MgO after storage was calculated by subtracting [3] from the mean mass of the tablet (mg) after storage. The true density of MgO was measured using a dry automatic pycnometer (AccuPyc 1330, Shimadzu Corporation, Kyoto, Japan) and the volume was calculated by dividing this mass by the determined density (3.17 g/mL).…”

Section: Calculation Of Tablet Porositymentioning

confidence: 99%

“…However, uncoated tablets are affected by the temperature, humidity, and light-exposure of their storage environment; humidity in particular often affects the physical properties of tablets by reducing hardness and changing (accelerating or delaying) their disintegration time. [1][2][3][4] For this reason, uncoated tablets are usually packaged using materials with a high moisture resistance, such as pillowtype packaging with aluminum foil. In recent years, however, uncoated tablets have also often been handled in an unpackaged state, such as in automatic tablet packing machines, to provide unit-dose packages that aim to improve the reliability of, and compliance to, drug therapies.…”

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confidence: 99%

“…The packaging materials used for unit-dose packaging are not generally completely moisture-resistant, and the tablets in these packages reportedly show decreased hardness. 4,5) Magnesium oxide (MgO) has frequently been used as a laxative and antacid and has been proven to be effective and safe. MgO tablets have also become widespread in recent years because they are easy to take.…”

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confidence: 99%

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Mechanism by Which Magnesium Oxide Suppresses Tablet Hardness Reduction during Storage

Sakamoto

Kachi

Nakamura

et al. 2016

CHEMICAL & PHARMACEUTICAL BULLETIN

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This study investigated how the inclusion of magnesium oxide (MgO) maintained tablet hardness during storage in an unpackaged state. Tablets were prepared with a range of MgO levels and stored at 40°C with 75% relative humidity for up to 14 d. The hardness of tablets prepared without MgO decreased over time. The amount of added MgO was positively associated with tablet hardness and mass from an early stage during storage. Investigation of the water sorption properties of the tablet components showed that carmellose water sorption correlated positively with the relative humidity, while MgO absorbed and retained moisture, even when the relative humidity was reduced. In tablets prepared using only MgO, a petal-or platelike material was observed during storage. Fourier transform infrared spectrophotometry showed that this material was hydromagnesite, produced when MgO reacts with water and CO 2 . The estimated level of hydromagnesite at each time-point showed a significant negative correlation with tablet porosity. These results suggested that MgO suppressed storage-associated softening by absorbing moisture from the environment. The conversion of MgO to hydromagnesite results in solid bridge formation between the powder particles comprising the tablets, suppressing the storage-related increase in volume and increasing tablet hardness.Key words hydromagnesite; relative humidity; unpackaged state; capillary condensation; mesopore Tablets are frequently used as a drug dosage form that is convenient for patients. However, uncoated tablets are affected by the temperature, humidity, and light-exposure of their storage environment; humidity in particular often affects the physical properties of tablets by reducing hardness and changing (accelerating or delaying) their disintegration time. [1][2][3][4] For this reason, uncoated tablets are usually packaged using materials with a high moisture resistance, such as pillowtype packaging with aluminum foil. In recent years, however, uncoated tablets have also often been handled in an unpackaged state, such as in automatic tablet packing machines, to provide unit-dose packages that aim to improve the reliability of, and compliance to, drug therapies. The packaging materials used for unit-dose packaging are not generally completely moisture-resistant, and the tablets in these packages reportedly show decreased hardness. 4,5) Magnesium oxide (MgO) has frequently been used as a laxative and antacid and has been proven to be effective and safe. MgO tablets have also become widespread in recent years because they are easy to take. [6][7][8] When stored for three months in an unpackaged state at 30°C with 75% relative humidity, these MgO tablets (Magmitt Tab ® , and Maglax Tab ® ) showed a 1.7-3.8-fold increase in hardness.9) MgO accounts for 86-88% of the mass of these tablets, strongly implying that MgO is involved in this increase in hardness. We have previously shown that MgO is useful as an excipient that suppresses the decline in tablet hardness caused by humidity.10)The...

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“…Color changes in pharmaceutical products are often indicative of either poor-quality production or product instability. 1,2) Color measurement is one type of quality assurance test that should be performed during the development of pharmaceutical products. 3) Techniques for preventing changes in the color of the product are often used.…”

mentioning

confidence: 99%

Prediction of Color Changes Using the Time–Temperature Superposition Principle in Liquid Formulations

Mochizuki

Takayama

2014

CHEMICAL & PHARMACEUTICAL BULLETIN

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This study reports the results of applying the time-temperature superposition principle (TTSP) to the prediction of color changes in liquid formulations. A sample solution consisting of L-tryptophan and glucose was used as the model liquid formulation for the Maillard reaction. After accelerated aging treatment at elevated temperatures, the Commission Internationale de l'Eclairage (CIE) LAB color parameters (a*, b*, L*, and E*ab) of the sample solution were measured using a spectrophotometer. The TTSP was then applied to a kinetic analysis of the color changes. The calculated values of the apparent activation energy of a*, b*, L*, and ΔE*ab were 105.2, 109.8, 91.6, and 103.7 kJ/mol, respectively. The predicted values of the color parameters at 40°C were calculated using Arrhenius plots for each of the color parameters. A comparison of the relationships between the experimental and predicted values of each color parameter revealed the coefficients of determination for a*, b*, L*, and ΔE*ab to be 0.961, 0.979, 0.960, and 0.979, respectively. All the R 2 values were sufficiently high, and these results suggested that the prediction was highly reliable. Kinetic analysis using the TTSP was successfully applied to calculating the apparent activation energy and to predicting the color changes at any temperature or duration.Key words color change; prediction; time-temperature superposition principle; Maillard reactionThe color of pharmaceutical products is an important quality attribute. Color changes in pharmaceutical products are often indicative of either poor-quality production or product instability.1,2) Color measurement is one type of quality assurance test that should be performed during the development of pharmaceutical products.3) Techniques for preventing changes in the color of the product are often used. For example, the use of antioxidant agents and color agents is a common solution for stabilizing the color appearance of products. 4) In some cases, however, color changes occur very slowly over time. If a commercialized product exhibits a color change before it can be sold, the product should be recalled. Therefore, a method for predicting color changes is important for the development of products within a short time period and for determining the shelf-life of a product. In the food industry, methods for predicting color changes over time have been thoroughly studied as an index of quality. Several reports have discussed the kinetics of color changes in food products, such as broccoli juice, 5) apple puree, 6) and green asparagus. 7) In the pharmaceutical industry, kinetic analyses of changes in the color of solid dosage forms have been reported with a variety of purpose, including the prediction of discoloration, 8) evaluations of the coloration of photosensitive solid drugs, 9) elucidation of the discoloration kinetics of uncoated white tablets, 10) examinations of coloration during long-term stability tests, 11) and the examination of color stabilization through the use of film coating.12) On the other...

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The most appropriate storage method in unit-dose package and correlation between color change and decomposition rate of aspirin tablets

Cited by 18 publications

References 1 publication

Automatic drug distribution systems (unit dose) in hospitals in Poland and in selected countries in the world

Automatic drug distribution systems (unit dose) in hospitals in Poland and in selected countries in the world

Mechanism by Which Magnesium Oxide Suppresses Tablet Hardness Reduction during Storage

Prediction of Color Changes Using the Time–Temperature Superposition Principle in Liquid Formulations

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