In-use Stability Study of Phloroglucinol and Nitroglycerin Sublingual Tablets Using Simulation Design after Opening of their Containers
Nary Woo, Namjin Lee*, Seungjae Lee*, Minyoung Kim, Minji Park, Jongpil Lee, and Won Shin
Drug Research Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Osong 187, Korea
*Pharmaceutical Product QC, SLS Bio co., Ltd., Suwon 107, Korea
*Pharmaceutical Product QC, SLS Bio co., Ltd., Suwon 107, Korea
Correspondence to: Won Shin
Drug Research Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Osong 187, Korea
Tel.: 043-719-4602 Fax.: 043-719-4600
E-mail: wshin@korea.kr
Drug Research Division, National Institute of Food and Drug Safety Evaluation (NIFDS), Osong 187, Korea
Tel.: 043-719-4602 Fax.: 043-719-4600
E-mail: wshin@korea.kr
Received June 29, 2017; Revised November 22, 2017; Accepted November 28, 2017.
- Abstract
- Expiration date of pharmaceuticals is established based on stability studies on the products. However it does not guarantee stability of pharmaceuticals once their containers are open. In particular pharmaceuticals stored in multi-dose container or the ones which require protection from moisture (e.g. sublingual tablets, effervescent tablets and dispersible tablets) need information on in-use stability after opening of their containers to maintain their safety, efficacy, and quality. It helps consumers to take pharmaceuticals safely. In order to study in-use stability of pharmaceuticals after opening of their containers, Phloroglucinol sublingual tablets and Nitroglycerin sublingual tablets which are sensitive to moisture or humidity were selected. Test methods were developed referring to the applicable EMA guideline, including withdrawal method to consider actual use of pharmaceuticals. The appearance, disintegration and potency of the Phloroglucinol sublingual tablets were evaluated at 1, 3 and 6 month after opening of containers. During 6 months, no difference in appearance and disintegration was found in different 3 lots. However, the potency of active ingredient was decreased gradually during 6 months and the results of 3 lots were 93.4%, 94.1% and 94.2%, respectively, which were out of in-house specification range (95.0~105.0%) of test product. In-use stability of Nitroglycerin sublingual tablets was also evaluated on appearance, disintegration, impurity and potency at 0.5, 1, 2, 3 and 6 month after opening of containers. During 6 months, no significant difference in appearance, disintegration and impurity were found in different 3 lots. However, the potency of active ingredient was decreased gradually during 6 months and the results of 3 lots was 82.1%, 83.2% and 84.1%, respectively, even though they were remained within the KP specification range (80.0~120.0%) of test product. Study results suggest product quality of sublingual tablets can be affected by opening of their containers. For safe and effective use of pharmaceuticals, we recommend the Phloroglucinol sublingual tablets and Nitroglycerin sublingual tablets be stored under the minimized moisture effect and used within 6 months after opening of their containers
- Keywords : In-use stability, simulation, Phloroglucinol, Nitroglycerin, sublingual tablets
- October 2024, 68 (5)
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