Comparative stability of repackaged metoprolol tartrate tablets

Yang, Yongsheng; Gupta, Abhay; Carlin, Alan S.; Faustino, Patrick J.; Lyon, Robbe C.; Ellison, Christopher D.; Rothman, Barry; Khan, Mansoor A.

doi:10.1016/j.ijpharm.2009.10.040

Cited by 13 publications

(9 citation statements)

References 3 publications

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“…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). [5] The tablet void volume (mL) was calculated by subtracting the sum of the volumes determined in [3] and [4] from the tablet volume (mL), which was calculated using the mean size and thickness after storage. The porosity was this void volume, expressed as a percentage of the tablet volume.…”

Section: Calculation Of Tablet Porositymentioning

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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Section: Calculation Of Tablet Porositymentioning

confidence: 99%

mentioning

confidence: 99%

Mechanism by Which Magnesium Oxide Suppresses Tablet Hardness Reduction during Storage

Sakamoto

Kachi

Nakamura

et al. 2016

CHEMICAL & PHARMACEUTICAL BULLETIN

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“…However, there is no published study under the ICH accelerated or long-term storage conditions investigating the stability of furosemide tablets repackaged in Class A unit-dose containers and comparing it to its stability in original containers. The work presented in this paper is part of an effort at the FDA laboratories to evaluate the stability of various dosage forms such as syrup (17), capsules (18) and tablets following repackaging (19). The current work concerns controlled stability studies that were conducted on a 40 mg furosemide tablet drug product in its original bottles vs repackaged drug product in blister packs at 25°C and 60% relative humidity (RH) for 1-12 months compared to accelerated conditions at 40°C and 75% RH for 1-3 months.…”

Section: Research Articlementioning

confidence: 99%

“…These data are contrary to a previous FDA repackaging study with metoprolol tablets formulated with hygroscopic excipients. When the repackaged metoprolol formulation was placed under stressed conditions the tablet hardness changed from 8 KP to 0 K, negatively impacting the product quality of the repackaged formulation and thus highlighting the potential to alter product performance [19].…”

Section: Tablet Hardnessmentioning

confidence: 99%

Comparative stability study of unit-dose repackaged furosemide tablets

Asafu-Adjaye

Carlin

Jefferson

et al. 2011

Clinical Research and Regulatory Affairs

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The stability of a 40 mg furosemide tablet drug product repackaged in a unit-dose USP class A blister pack and the identical product in its original container made of HDPE material was studied under ICH long-term conditions of 25°C and relative humidity (RH) of 60% and accelerated stressed conditions of 40°C and 75% RH. Samples from original and repackaged drug products were periodically removed from storage conditions and subjected to pharmaceutical and spectroscopic analysis. Results indicate the potency 91.5 ± 0.9% of the tablet strength for the original packaging drug product vs 91.6 ± 4.0% for the repackaged product are statistically similar for long-term and accelerated stress conditions. Tablet hardness (6.0 ± 0.3 KP) and loss on drying (3.2%) was the same for original and repackaged drug products under both stressed conditions indicating similar moisture sorption behavior. Non-invasive spectroscopic techniques did not show any differences in moisture content. Dissolution and TGA results were similar for all study samples. In conclusion, contrary to a previous FDA repackaging study for tablets with hygroscopic excipients, the product quality attributes of furosemide tablets formulated with low sorption excipients were not affected by repackaging, under the specific stress conditions of this study.

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“…Only a handful of medications have been investigated for their stability following repackaging into MCAs, namely metoprolol, aspirin, atenolol, clozapine, furosemide, paracetamol, prochlorperazine and sodium valproate …”

Section: Introductionmentioning

confidence: 99%

Investigating the physical stability of repackaged medicines stored into commercially available multicompartment compliance aids (MCAs)

Raimi-Abraham

Valle

Galcera

et al. 2017

J Pharm Health Serv Res

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BackgroundCompliance aids are devices which have been developed and are currently used to assist individuals in their medicines management. The use of compliance aids involves the transfer of medicines from the manufacturers' original packaging and repackaged into an multicompartment compliance aid (MCA). MCAs do not guarantee the same level of protection compared to manufacturer's original packaging.ObjectiveThe aim of this study was to investigate the stability profile of atenolol, aspirin and lansoprazole dosage forms repackaged together in two different commercially available MCAs.MethodsIn a laboratory in the United Kingdom, the physical stability of the formulations repackaged into two commercially available brands of MCAs was evaluated. After 8 weeks of storage (under controlled ambient conditions), changes in the disintegration (tablets only) and dissolution properties (all formulations) were examined in accordance with British Pharmacopoeia (BP) specifications.Key findingsFindings from this study confirm that changes in solid‐dosage form quality are observed when repackaged into MCAs compared to manufacturers packaging resulting in differences in in‐vitro dissolution performance. However, even with these changes, overall product performance was acceptable and within BP specifications.ConclusionThere is a need for greater collaboration in this area between manufacturers, hospital and community pharmacists, academics and policymakers to increase the data available on the physical stability and in turn performance of medicines repackaged into MCAs.

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Comparative stability of repackaged metoprolol tartrate tablets

Cited by 13 publications

References 3 publications

Mechanism by Which Magnesium Oxide Suppresses Tablet Hardness Reduction during Storage

Mechanism by Which Magnesium Oxide Suppresses Tablet Hardness Reduction during Storage

Comparative stability study of unit-dose repackaged furosemide tablets

Investigating the physical stability of repackaged medicines stored into commercially available multicompartment compliance aids (MCAs)

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