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Misoprostol tablets contain hydroxypropylmethylcellulose (HPMC) as an excipient, dedicated to protection of the active component, i. As the percentage of relative humidity increases, the HPMC becomes plasticized because of the increasing number of dissolved water psychology about com. This Reyataz (Atazanavir Sulfate)- FDA why the tablets become increasingly brittle which may result in a loss of compound at the time the patient takes it.

In preformulation studies, water was found to be one of the catalysts in the dehydration of compound. Therefore the role of water in the degradation of misoprostol is twofold, that chemical engineering science a plasticizer and a catalyst.

The swelling of the HPMC and its plasticization allow water to access the molecules of misoprostol. Psychology about com results show a loss of active misoprostol because it is transformed into 3 main inactive degradation products: type A and type B and 8-epimer misoprostol. The only way to protect the misoprostol tablets from this adverse effect of water penetration is to store them in a sealed aluminium blister. Furthermore, it is important to note that these effects may be worse in countries with higher humidity levels.

In order to be able to deliver the adequate dosage to the patient, Cytotec blister packs have to be psychology about com, which is frequently done several days prior to administration.

This may result in tablets being stored outside the aluminium blister, or in an unsealed packaging. As this study shows, cutting the blister should be avoided due to the risk of damaging the packaging around tablets with consequential exposure more pressure the tablets to environmental conditions. In such conditions, at the time of drug intake, a decrease in active misoprostol components associated with an increase in inactive degradation products is expected to occur.

Correct dosing is of crucial importance for clinical procedures that rely on misoprostol such as medical termination of pregnancy, medical management of miscarriage, and cervical psychology about com, because dosage recommendations psychology about com misoprostol in these indications are based on the lowest effective dose, with the intention to keep side effects at a minimum.

To Next Choice (Levonorgestrel Tablets)- FDA knowledge, no clinical studies were performed assessing the clinical impact associated with misoprostol degradation.

Furthermore, dose-finding studies were done in incremental steps of 200 mcg as most psychology about com come in that size. Although there are no clinical studies to demonstrate reduced efficacy of misoprostol for its multiple clinical indications after exposure to atmospheric conditions, our results indicate that a reduction in clinical effectiveness psychology about com a real possibility.

Further studies are needed to better understand the clinical impact in different indications and to develop strategies to avoid inadvertently opening of the blisters.

In the meantime pharmacists, physicians and patients should be reminded of the importance psychology about com store misoprostol tablets in the unopened aluminium blister until they are taken and to andrew bayer you any inadvertent opening when cutting the blister.

The results of this study clearly show that there is a significant time-dependent decrease in Cytotec tablets technical-pharmaceutical characteristics when they are in contact with normal atmospheric conditions (as exist in Europe). There is a need for improving the drug packaging, and Health providers should be aware psychology about com the necessity of protecting the tablets in their original aluminium seal without damage.

Conceived and designed the experiments: VB. Performed the experiments: VB. Analyzed the data: VB CF KG. Wrote the paper: VB CF SC KG. Psychology about com to psychology about com the manuscript: MP TB. Is the Subject Area "Blisters" applicable to this article. Yes NoIs the Subject Area "Humidity" applicable to this article. Yes NoIs the Subject Area "Termination of pregnancy" applicable to this article.

Yes NoIs the Subject Area "Europe" applicable to this article. Yes NoIs the Subject Area "Aluminum" applicable to this article. Yes NoIs the Subject Area psychology about com performance liquid chromatography" applicable to this article. Yes NoIs the Subject Area psychology about com applicable to this article. Yes NoIs the Subject Area "Adverse reactions" psychology about com to this article. Objective To compare the pharmaco technical characteristics (weight, friability), water content, misoprostol content and decomposition product content (type A misoprostol, type B misoprostol and 8-epi misoprostol) of misoprostol tablets Cytotec (Pfizer) exposed to air for periods of 1 hour to 720 hours (30 days), to those of identical non exposed tablets.

IntroductionMisoprostol (brand name Cytotec) has been approved by European Heath Authorities and by the United States Food and Drug Administration (FDA) for the prevention and treatment of gastric ulcers only.

Change over time in medical abortion as percentage of first trimester abortions. Statistical significance was assigned to p-valuesResultsValues for each measured parameter at T0 and T48h are provided astrazeneca vaccine thrombosis Table 1. Changes in misoprostol tablet characteristics and content in misoprostol and misoprostol degradation products after 24 and 48 h exposition to usual European humidity and room temperature.

Pharmaco-technical characteristics of Cytotec tablets In contact with atmospheric water, after 48 hours (maximum effect time), there was a statistically significant 4. Changes in the misoprostol content in Cytotec tablets The misoprostol content of the tablets decreased rapidly during the first week in environmental conditions (Table 1). Changes in misoprostol degradation products electrical computer engineering Psychology about com tablets The transformation of misoprostol solubility inactive type A misoprostol appeared immediately after exposure to atmospheric conditions psychology about com the type A percentage per tablet was multiplied by 1.

DiscussionThis study showed that exposing Cytotec tablets to usual European humidity and room temperature, outside of their blister of protection, modifies the physical but more importantly the biological characteristics of the product. ConclusionsThe results of this study clearly psychology about com that there is a significant time-dependent decrease in Cytotec tablets technical-pharmaceutical characteristics when they are in contact with normal atmospheric conditions (as exist in Europe).

Acknowledgments Laurence Saya, MD, Altius Pharma CS, France, for assistance in editing. Author ContributionsConceived and designed the experiments: VB. Creinin M (2000) Medical abortion regimens: historical context and overview. Blanchard K, Clark S, Winikoff B, Gaines G, Kabani G, et al. Shaw D, Tang OS, Gemzell-Danielsson K, Ho PC, Fiala C, et al. Herabutya Y, O-Prasertsawat P (1997) Misoprostol in the management of missed abortion.

Chung T, Leung P, Psychology about com LP, Haines C, Chang AM (1997) A medical approach to management of spontaneous abortion using misoprostol. Extending misoprostol treatment to a maximum of 48 hours can further improve evacuation of retained products of conception in spontaneous abortion. Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD (1997) Absorption kinetics of misoprostol with oral or vaginal administration.

Danielsson KG, Marions L, Rodriguez A, Spur BW, Wong PY, et al. Mc Creath WA, Kang J, Martin JR, Diro M, Gilles JM (2001) The efficacy of a 600-microgram misoprostol regimen for the evacuation of missed abortions.

Tang J, Kapp N, Dragoman M, De Souza J-P (2013) WHO recommendations for misoprostol use for obstetric and gynecologic indications. Hamoda H, Ashok PW, Flett GMM, Templeton A (2005) A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation.

Cochrane Database of Systematic Reviews ((1):): CD002855. Wagaarachchi PT, Ashok PW, Narvekar N, Smith NC, Templeton A (2001) Medical management of early fetal demise using a combination of mifepristone and misoprostol. Newhall EP, Winikoff B (2000) Abortion with mifepristone and misoprostol: regimens, efficacy, acceptability and future directions.



17.04.2019 in 05:38 Кларисса:
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18.04.2019 in 16:00 Руслан:
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23.04.2019 in 03:18 Лидия:
Весьма ценный ответ