A Relative Bioavailability Study of Two Misoprostol Formulations Following a Single Oral or Sublingual Administration

Amini, Mahdi; Reis, Margareta; Wide‐Swensson, Dag

doi:10.3389/fphar.2020.00050

Cited by 9 publications

(9 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The World Health Organization (WHO) has included Misoprostol in the list of essential drugs due to its properties and its optimal profile in terms of costs and benefits, thus resulting in an extremely efficient, appropriate and economic drug (14). Misoprostol explicates its action on the cervix by stimulating contractions and facilitating cervical ripening and dilatation (15). An extended bibliography supports the evidence and recommendations that confirm Misoprostol to be superior and more efficient compared to drugs containing PGE2 (16)(17)(18)(19)(20)(21)(22)(23).…”

Section: Misoprostolmentioning

confidence: 62%

Italian Society of Gynaecology and Obstetrics (SIGO): Consensus paper on induction of labor with oral administration of Misoprostol

et al. 2021

View full text Add to dashboard Cite

Section: Misoprostolmentioning

confidence: 62%

Italian Society of Gynaecology and Obstetrics (SIGO): Consensus paper on induction of labor with oral administration of Misoprostol

et al. 2021

View full text Add to dashboard Cite

“… 9 , 12 , 25 , 26 The CL/F b and V/F b of MPA in our study were consistent with the PKs observed in a recent study comparing bioavailability of two formulations of misoprostol following oral and sublingual administration in full‐term women. 18 Thus, it appears that clearance of MPA in the third trimester of pregnancy is increased compared to non‐pregnant and first‐trimester pregnant women.…”

Section: Discussionmentioning

confidence: 99%

“… 11 Recently, Amini et al reported PKs of two formulations of misoprostol following oral and sublingual administration at term. 18 To our knowledge, no study has compared the PKs of vaginal versus buccal administration of misoprostol for full‐term labor induction.…”

Section: Introductionmentioning

confidence: 99%

“…One study describes the PKs of MPA following rectal or oral administration of 600 μg misoprostol during the third stage of labor 11 . Recently, Amini et al reported PKs of two formulations of misoprostol following oral and sublingual administration at term 18 . To our knowledge, no study has compared the PKs of vaginal versus buccal administration of misoprostol for full‐term labor induction.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetics of vaginal versus buccal misoprostol for labor induction at term

Vorontsova

Haas

Flannery

et al. 2022

Clinical Translational Sci

View full text Add to dashboard Cite

The IMPROVE study (NCT02408315) compared the efficacy and safety of vaginal and buccal administration of misoprostol for full‐term, uncomplicated labor induction. This report compares the pharmacokinetics of misoprostol between vaginal and buccal routes. Women greater than or equal to 14 years of age undergoing induction of labor greater than or equal to 37 weeks gestation without significant complications were randomized to vaginal or buccal misoprostol 25 μg followed by 50 μg doses every 4 h. Misoprostol acid concentrations were determined using liquid chromatography‐tandem mass spectrometry for the first 8 h in a subgroup of participants. A population pharmacokinetic model was developed using NONMEM. Plasma concentrations ( n = 469) from 47 women were fit to a one‐compartment nonlinear clearance model. The absorption rate constant (k a ) was dependent on both route and dose of administration: buccal 25 μg 0.724 (95% confidence interval, 0.54–0.92) h −1 ; 50 μg 0.531 (0.37–0.63) h −1 ; vaginal 25 μg 0.507 (0. 2–1. 4) h −1 ; and 50 μg 0.246 (0.103–0.453) h −1 . Relative bioavailability for vaginal compared to buccal route was 2.4 (1.63–4.77). There was no effect of body mass index or age on apparent clearance 705 (431–1099) L/h or apparent volume of distribution 632 (343–1008) L. The area under the concentration–time curve to 4 h following the first 25 μg dose of misoprostol was 16.5 (15.4–17.5) pg h/ml for buccal and 34.3 (32.5–36.1) pg h/ml for vaginal administration. The rate of buccal absorption was two times faster than that of vaginal, whereas bioavailability of vaginal administration was 2.4 times higher than that of buccal. Decreased time to delivery observed with vaginal dosing may be due to higher exposure to misoprostol acid compared to buccal.

show abstract

“…Sublingual route was used assuming that it has higher efficacy than vaginal route [5] . It also avoids the first pass effects of gastrointestinal and hepatic systems [6] . while uterine hyperstimulation rates may be the same as vaginal misoprostol [7] .…”

Section: Discussionmentioning

confidence: 99%

Induction of labour with foley catheter is better alternative to misoprostol

Biswas¹,

Sengupta²,

Ray³

et al. 2020

Int. J. Clin. Obstet. Gynaecol.

View full text Add to dashboard Cite

AIM-The aim of this study was to compare the efficacy of induction of labour with Foley balloon inflation to 60ml with sublingual misoprostol. MATERIALS AND METHODS -This randomised controlled trial (n= 320) was performed on women with singleton pregnancy with cephalic presentation and unfavourable cervix admitted in RG Kar Medical College during the period of July 2011 to June 2012. In Foley group, labour was induced by placing No. 20 transcervical Foley catheter and inflating the balloon to 60 ml along with intravenous oxytocin. In Misoprostol group, sublingual misoprostol was used, 25 mcg every 4 hours to a maximum of 5 doses until adequate uterine contractions. Intravenous oxytocin was administered in patients with protraction or arrest disorders. RESULTS -The two groups were similar in demographic characteristics, indication for induction, pre-induction Bishop score, maternal and fetal complications. Time from induction to delivery was significantly shorter in Foley catheter group compared to misoprostol group(15.19+2.83 vs 16.16+3.35 hr, p<0.05). Mean post induction Bishop Score at 6 hours and 12 hours was significantly higher in Foley catheter group compared to misoprostol group (5.98+1.46 vs 4.95+1.33 and 8.45+1.5 vs 7.12+1.6, p<0.05). CONCLUSION -labour induction with Foley catheter is a safe and effective method of with less induction to delivery time. It avoids the side effects of misoprostol like nausea, vomiting, diarrhoea, fever shivering as well as uterine complications like tachysystole, rupture, and fetal death. CLINICAL SIGNIFICANCE -Induction of labour by Transcervical foley is a better alternative to misoprostol and should me more widely used.

show abstract

A Relative Bioavailability Study of Two Misoprostol Formulations Following a Single Oral or Sublingual Administration

Cited by 9 publications

References 21 publications

Italian Society of Gynaecology and Obstetrics (SIGO): Consensus paper on induction of labor with oral administration of Misoprostol

Italian Society of Gynaecology and Obstetrics (SIGO): Consensus paper on induction of labor with oral administration of Misoprostol

Pharmacokinetics of vaginal versus buccal misoprostol for labor induction at term

Induction of labour with foley catheter is better alternative to misoprostol

Contact Info

Product

Resources

About