Evaluation of the Photodegradation of Crushed- and Suspended Pranoprofen Tablets

Kawabata, Ken‐ichi; Ishida, Mai; Akimoto, Shiori; Inagaki, Michio; Nishi, Hiroyuki

doi:10.15583/jpchrom.2021.015

Cited by 11 publications

(5 citation statements)

References 14 publications

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“…Colors of samples of generic amlodipine OD tablets after UV irradiation had not changed as in AML OD tablets and NOR OD tablets. This indicates that the photodegradability of amlodipine was enhanced by changing the dosage form from tablets to powders and suspensions, as shown in our previous reports [12,13]. Light emission efficiency of suspension samples is more significant compared to powder samples.…”

Section: Photostabilities Of Amlodipine Od Tablets Their Powdered And...supporting

confidence: 72%

“…Our previous reports showed that photostabilities of several medicines, including naproxen and pranoprofen tablets, decrease when crushed or suspended tablets are exposed to UV irradiation [12,13]. The different dosage forms and single-dose packaging of several medicines are useful methods to improve the medication compliance of patients, but the beneficial effect of medicines might be weakened when APIs are photodegraded.…”

Section: Introductionmentioning

confidence: 99%

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Photostabilities of Amlodipine OD Tablets in Different Dosage Forms

et al. 2022

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Amlodipine is a dihydropyridine drug that is used to lower high blood pressure. In this study, the photostabilities of orally disintegrating (OD) amlodipine tablets, both original and generic versions, and their powdered and suspended forms were evaluated. The concentration of the active pharmaceutical ingredient (API) was monitored by high-performance liquid chromatography (HPLC), revealing that residual amounts of API in powders and suspensions significantly decreased after ultraviolet light (UV) irradiation for 24 hr. Amlodipine OD tablets and their powders were packaged and stored at a house and a pharmacy for up to 90 days for the evaluation of their photostabilities in clinical use, and that amounts of API in the powdered form significantly decreased when they were stored in the house. ESI-LC/MS/MS analysis was performed to determine the chemical structure of photoproducts generated by photo-irradiated amlodipine OD tablets. It revealed that mainly a dehydrogenated form of amlodipine was generated concomitant with the photodegradation by UV and sunlight irradiation. This is the first study that evaluated the photostabilities of original amlodipine OD medicines, their generic OD versions and their altered forms.

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Section: Photostabilities Of Amlodipine Od Tablets Their Powdered And...supporting

confidence: 72%

Section: Introductionmentioning

confidence: 99%

Photostabilities of Amlodipine OD Tablets in Different Dosage Forms

et al. 2022

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“…Similarly to the HPLC chromatogram, residual amounts of APIs were not influenced by UV irradiation when tablet samples were irradiated. These results indicated that changing the dosage form of SPL tablets to powders and suspensions decreases the photostability because of the loss of a film coating and the enhancement of a light emission efficiency to their APIs, as shown in our previous reports [ 29 ]. It is possible that the crushing of SPL tablets for the improvement of medication compliance in a clinical situation might result in the decrease in its beneficial effect when SPL powders are packaged and stored in a place where they are exposed to sunlight.…”

Section: Resultssupporting

confidence: 80%

Structure Determination of Felodipine Photoproducts in UV-Irradiated Medicines Using ESI-LC/MS/MS

Kawabata

Kohashi

Akimoto³

et al. 2023

Pharmaceutics

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Dihydropyridine drugs are well known as photodegradable pharmaceuticals. Herein, we evaluate the photostability of felodipine (FL) medicine (Splendil® (SPL) tablets) and its altered forms (powders and suspensions). FL is a type of dihydropyridine drug, but its photochemical behavior is unknown. FL contents after ultraviolet light (UV) irradiation for 24 h were monitored using high-performance liquid chromatography (HPLC). Values of the residual amounts of FL in UV-irradiated SPL powders and suspensions were 32.76 ± 4.88% and 0.79 ± 0.74%, respectively, with the generation of two photoproducts (FL photoproduct 1 and 2). To identify the chemical structures of these photoproducts, electrospray ionization liquid chromatography mass spectrometry (ESI-LC/MS/MS) analysis was performed. Based on their mass-to-charge ratio values and fragment patterns, it was proposed that FL photoproduct 1 was a pyridine derivative and FL photoproduct 2 was an FL dimer. Interestingly, generation rates of FL photoproduct 1 and 2 were dependent on the presence of the aqueous media. The photodimerization of FL was induced in UV-irradiated SPL suspensions. This is the first report evaluating the photostability of SPL tablets and its altered forms and estimating FL photoproducts induced by UV irradiation in the formulation of SPL.

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“…Next, the photostability evaluation of several tablets including NSAIDs and dihydropyridine drugs and their powders and suspensions was performed. The effect of UV irradiation on nine NSAIDs tablets was evaluated as shown in Table 1 [47,48]. Residual amounts of APIs did not decrease when the tablets were UV-irradiated.…”

Section: The Photostability Evaluation Of Several Medicines and Their...mentioning

confidence: 99%

Evaluation of Photostability of Medicines and Development of the Photostabilization of the Photosensitive Medicines

Kawabata

Nishi

2023

Chromatography

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Photo-exposure has a crucial effect on both the quality and quantity of photosensitive pharmaceuticals due to the decrease of their contents or the expression of adverse effects derived from generated photoproducts. The photostability test guidelines (ICH-Q1B, Photostability testing of new drug substances and products) have been established for the photostability evaluation in the new drug application, and obtained results from these tests are required for the elucidation of the final packaging and the dosage form. However, there is no information in the interview form about the photostability of medicines that are taken out from a press through package (PTP) sheet and their dosage forms are changed for the purpose of the improvement of medication compliance of patients. It is an important issue to clarify the photostability of medicines that are crushed or suspended and determine the potential photoproducts for safe use. Herein, in this review, results of the evaluation of the photodegradability of photosensitive active pharmaceutical ingredients (APIs) and their formulations, the determination of several photoproducts generated by ultraviolet-light (UV) irradiation and the development of photostabilization strategy for them based on the addition of several photostabilizers are summarized.

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Evaluation of the Photodegradation of Crushed- and Suspended Pranoprofen Tablets

Cited by 11 publications

References 14 publications

Photostabilities of Amlodipine OD Tablets in Different Dosage Forms

Photostabilities of Amlodipine OD Tablets in Different Dosage Forms

Structure Determination of Felodipine Photoproducts in UV-Irradiated Medicines Using ESI-LC/MS/MS

Evaluation of Photostability of Medicines and Development of the Photostabilization of the Photosensitive Medicines

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