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Journal of Research in Medical Sciences... 2021Postpartum pain contributes to increased irritability and excessive stress in the mother and consequently may inhibit successful breastfeeding, reduce a mother's ability...
BACKGROUND
Postpartum pain contributes to increased irritability and excessive stress in the mother and consequently may inhibit successful breastfeeding, reduce a mother's ability to take care of her baby, and cause an imperfect mother-baby interaction. Evidence suggests the positive effect of ginger on reduction in uterus-associated pain. The objective of this study is to investigate the effect of ginger capsules on postpartum pain.
MATERIALS AND METHODS
The present double-blinded, randomized, placebo-controlled trial was conducted in Mahdiyeh Educational Hospital, Tehran. One hundred and twenty-eight mothers having moderate-to-severe pain following vaginal delivery were included. The participants were divided into two groups (A and B). Interventions were performed every 8 h in 24 h. In the first intervention (2 h after the delivery), Group A received 500 mg of placebo capsules (containing chickpea flour) and Group B received 500 mg of Zintoma (ginger rhizome) capsules. In the second and third interventions, Group A received 250 mg placebo capsules and Group B received 250 mg Zintoma capsules. All participants received 250 mg capsules of mefenamic acid in each intervention in addition to ginger or placebo capsules. The pain severity was measured before and half an hour, an hour, and 2 h after each intervention. Statistical analysis was performed using the SPSS software version. 22. The Chi-square, Fisher's, and t tests and the GEE model were applied to assess the pain severity.
RESULTS
The average pain severity was not statistically significant between the groups in the beginning of the intervention ( = 0.623). The mean score of pain significantly decreased within the duration of intervention in both groups ( < 0.001); however, the pain severity was significantly lower in the intervention group as compared to the control group at any point after the intervention ( = 0.006).
CONCLUSION
Ginger can be used as an effective remedy for postpartum pain relief.
PubMed: 35126568
DOI: 10.4103/jrms.JRMS_544_20 -
Colloids and Surfaces. B, Biointerfaces Apr 2022Synthetic single-chain bolalipids with symmetrical headgroups have shown potential in various pharmaceutical applications, such as the stabilization of liposome...
Synthetic single-chain bolalipids with symmetrical headgroups have shown potential in various pharmaceutical applications, such as the stabilization of liposome bilayers. Despite their amphiphilic character, synthetic bolalipids have not yet been investigated for their suitability as solubilizing agents for poorly soluble drug compounds. In this study, three synthetic single-chain bolalipids with increasing alkyl chain lengths (C22, C24 and C26) were investigated. All three bolalipids were able to achieve an increased solubility of the model drug, mefenamic acid, by approximately 180% in a pH 7.4 buffer compared to only a 102-105% increase achieved by sodium dodecyl sulfate (SDS) or the non-ionic surfactant pegylated hydroxystearate (PEG-HS). Subsequently, interfacial activity of bolalipids and their ability to destabilize liposomal bilayers were investigated. The C22 bolalipid exhibited a consistently lower interfacial activity, which was consistent with its significantly lower cytotoxicity in the macrophage-like cell line, J774. A1, compared to C24 and C26 counterparts. The mean IC values of the bolalipids tested (0.035-0.093 mM) were approximately 4-100-fold lower than that of SDS (0.401 mM) or PEG-HS (0.922 mM), with the mechanism of toxicity linked to increased cell membrane permeability, as is expected for surfactants. In summary, evidence from this study shows that decreasing the length of the bolalipid alkyl linker from C26 to C22 resulted in a significantly decreased cytotoxicity with no loss in drug solubilization efficiency.
Topics: Excipients; Liposomes; Micelles; Sodium Dodecyl Sulfate; Solubility; Surface-Active Agents
PubMed: 35123195
DOI: 10.1016/j.colsurfb.2022.112369 -
International Journal of Pharmaceutics Mar 2022The objective of this study was to develop an immediate release (IR), crystalline solid dispersion (CSD) formulation of Mefenamic acid (MFA) by hot-melt-extrusion (HME)...
The objective of this study was to develop an immediate release (IR), crystalline solid dispersion (CSD) formulation of Mefenamic acid (MFA) by hot-melt-extrusion (HME) and assess the impact of drug loading on process parameters, product physico-chemical properties and product performance. An HME process to produce a range of MFA-Soluplus®-Sorbitol polymer matrix CSD formulations was developed based on rheological screening assays of physical mixtures (PM). The impact of drug loading on process parameters was compared to the impact of drug loading on the physico-chemical properties of formulations. Based on process and product data, three groupings of API drug loading were identified: sub-saturated, saturated, and supersaturated systems. CSD formulations were obtained for 20-50% (w/w) drug loading containing the stable polymorphic form I of MFA. CSD formulations predominantly improved the consistency of the product performance. An Amorphous Solid Dispersion (ASD) was obtained for 10% (w/w) drug loading, exhibiting faster drug release even at physiologically relevant pH. This study illustrates the impact of drug loading on process and product characteristics and how a better understanding of maximum API solubility in a given polymer system can improve targeted formulation development.
Topics: Chemistry, Pharmaceutical; Drug Compounding; Drug Liberation; Hot Melt Extrusion Technology; Hot Temperature; Mefenamic Acid; Solubility
PubMed: 35085732
DOI: 10.1016/j.ijpharm.2022.121505 -
Green electrochemical method for the synthesis of nitro and azo derivatives based on mefenamic acid.Scientific Reports Jan 2022Electrochemical study of mefenamic acid (MFA) was carried out with details in water/ethanol mixture by the various voltammetric techniques. The results showed that the...
Electrochemical study of mefenamic acid (MFA) was carried out with details in water/ethanol mixture by the various voltammetric techniques. The results showed that the oxidation of MFA is highly dependent on pH and follows the E mechanism. The E-pH diagram plotted based on the differential pulse voltammograms shows two linear segments, 66 and 26 mV/pH slope. Also, the diffusion coefficient and the surface excess, Ӷ* of MFA in aqueous buffered solution, determined by using the single potential-step chronoamperometry and chronocoulometry methods. Electrochemical nitration of MFA in an aqueous solution and the presence of nitrite ion (1) were both investigated by the cyclic voltammetry and controlled-potential coulometry techniques. Our results indicate that the oxidized form of MFA participates in a Michael-type addition reaction with nitrite ion (1) to form the corresponding Nitromefenamic acids (MFA-4-NO and MFA-5-NO). Also, in another part, a computational study based on the density functional theory (DFT/B3LYP) was performed for the prediction of the best possible pathway in the nucleophilic addition of nitrite ion (1). The electrochemical reduction of produced nitromefenamic acids was investigated using cyclic voltammetry and controlled-potential coulometry techniques. Eventually, two new azo derivatives have been generated via electroreduction of produced nitromefenamic acids and conduction of diazotization reaction, respectively. Both nitro and azo products are approved as paints.
PubMed: 35058526
DOI: 10.1038/s41598-022-05009-0 -
European Journal of Pharmaceutics and... Jan 2022After oral administration, a drug's solubility in intestinal fluid is an important parameter influencing bioavailability and if the value is known it can be applied to...
After oral administration, a drug's solubility in intestinal fluid is an important parameter influencing bioavailability and if the value is known it can be applied to estimate multiple biopharmaceutical parameters including the solubility limited absorbable dose. Current in vitro measurements may utilise fasted human intestinal fluid (HIF) or simulated intestinal fluid (SIF) to provide an intestinal solubility value. This single point value is limited since its position in relation to the fasted intestinal solubility envelope is unknown. In this study we have applied a nine point fasted equilibrium solubility determination in SIF, based on a multi-dimensional analysis of fasted human intestinal fluid composition, to seven drugs that were previously utilised to investigate the developability classification system (ibuprofen, mefenamic acid, furosemide, dipyridamole, griseofulvin, paracetamol and acyclovir). The resulting fasted equilibrium solubility envelope encompasses literature solubility values in both HIF and SIF indicating that it measures the same solubility space as current approaches with solubility behaviour consistent with previous SIF design of experiment studies. In addition, it identifies that three drugs (griseofulvin, paracetamol and acyclovir) have a very narrow solubility range, a feature that single point solubility approaches would miss. The measured mid-point solubility value is statistically equivalent to the value determined with the original fasted simulated intestinal fluid recipe, further indicating similarity and that existing literature results could be utilised as a direct comparison. Since the multi-dimensional approach covered greater than ninety percent of the variability in fasted intestinal fluid composition, the measured maximum and minimum equilibrium solubility values should represent the extremes of fasted intestinal solubility and provide a range. The seven drugs all display different solubility ranges and behaviours, a result also consistent with previous studies. The dose/solubility ratio for each measurement point can be plotted using the developability classification system to highlight individual drug behaviours. The lowest solubility represents a worst-case scenario which may be useful in risk-based quality by design biopharmaceutical calculations than the mid-point value. The method also permits a dose/solubility ratio frequency distribution determination for the solubility envelope which permits further risk-based refinement, especially where the drug crosses a classification boundary. This novel approach therefore provides greater in vitro detail with respect to possible biopharmaceutical performance in vivo and an improved ability to apply risk-based analysis to biopharmaceutical performance. Further studies will be required to expand the number of drugs measured and link the in vitro measurements to in vivo results.
Topics: Administration, Oral; Biological Availability; Biopharmaceutics; Humans; Hydrogen-Ion Concentration; Intestinal Absorption; Intestinal Secretions; Pharmaceutical Preparations; Solubility
PubMed: 34923138
DOI: 10.1016/j.ejpb.2021.12.006 -
Brazilian Journal of Biology = Revista... 2021Rubiadin is identified as a bioactive anthraquinone that exists in some quinone rich plants. The current research was carried out to evaluate the potential...
Rubiadin is identified as a bioactive anthraquinone that exists in some quinone rich plants. The current research was carried out to evaluate the potential anti-inflammatory impact of Rubiadin in acute and chronic inflammation test models in rodents. The anti-inflammatory activity of Rubiadin was examined in cotton pellet-induced granuloma and carrageenan-induced edema as chronic and acute inflammation models in rats. TNF-α level and histopathological changes were assessed using sampled foot tissue of rat in the acute model. Also, the IL-1β level was assessed in the chronic model. One-way ANOVA (post hoc Tukey's) analysis was used for comparing the groups. Rubiadin (0.5 mg/kg, i.p.) induced a significant reduction in TNF α level and the paw edema compared to the control group in carrageenan test. Also, it was observed that the anti-inflammatory activity of Rubiadin (0.5 mg/kg, i.p.) is comparable to mefenamic acid (30 mg/kg, i.p.) as the standard drug. Rubiadin was effective in granuloma induced by cotton pellet concerning the granuloma and transudate formation amount. Rubiadin's anti-inflammatory effects were associated with a significant IL-1β decrease in this model. The results suggest that Rubiadin as a natural compound can possess significant peripheral anti-inflammatory impacts.
Topics: Animals; Anthraquinones; Anti-Inflammatory Agents; Carrageenan; Edema; Inflammation; Plant Extracts; Rats; Rodentia
PubMed: 34909834
DOI: 10.1590/1519-6984.243775 -
Avicenna Journal of Phytomedicine 2021Postpartum pain (PP pain) is a common problem after vaginal delivery. Some herbs are used to reduce PP pain. Due to the anti-inflammatory properties of (wheat) germ,...
OBJECTIVE
Postpartum pain (PP pain) is a common problem after vaginal delivery. Some herbs are used to reduce PP pain. Due to the anti-inflammatory properties of (wheat) germ, this study was conducted to investigate the effect of wheat germ on PP pain.
MATERIALS AND METHODS
This is a randomized, double-blind, placebo-controlled clinical trial performed on 90 women who had a vaginal delivery and complained of moderate to severe PP pain. The participants were randomly divided into two groups. In the intervention group, a capsule containing 500 mg of wheat germ was taken every 6 hr for 2 days and in the control group, a placebo capsule was taken in the same order. The severity of PP pain was measured before and one hour after receiving the capsule by using the Visual Analogue Scale.
RESULTS
The two groups were not different in terms of pain severity before the intervention. The PP pain in women with moderate pain was significantly reduced in both groups, the reduction was greater in the wheat germ group (GEE=0.04) but this reduction was not significant. The PP pain in women with severe pain was significantly reduced in both groups, however, the reduction was significantly greater in the wheat germ group (GEE=0.63, p=0.007). Moreover, the results showed that the use of mefenamic acid in the wheat germ group was significantly lower than the control group (p=0.04). Moreover, no side effect was reported after consuming the wheat germ.
CONCLUSION
It seems that wheat germ reduces severe PP pain. Further research on this plant is recommended.
PubMed: 34804895
DOI: 10.22038/AJP.2021.18179 -
BMC Women's Health Nov 2021Primary dysmenorrhea (PD) is one of the most common gynecological conditions among young females, which has a significant negative impact on health-related quality of...
BACKGROUND
Primary dysmenorrhea (PD) is one of the most common gynecological conditions among young females, which has a significant negative impact on health-related quality of life and productivity. Despite its high prevalence, the evidence is limited regarding the management-seeking practices and its perceived effectiveness among females with PD.
METHODS
This is a cross-sectional study conducted among 550 female students in six universities across Lebanon. The prevalence of PD, associated risk factors, and management-seeking practices were assessed using a self-administered questionnaire.
RESULTS
The prevalence of PD was 80.9%. Most of the females with PD described their menstrual pain as moderate (56%) to severe (34.6%), which significantly affected their daily activities and studying ability (P < 0.001). The major risk factors associated with PD included heavy menstrual flow (adjusted odds ratio [AOR] = 10.28), family history of PD (AOR = 2.52), history of weight loss attempt (AOR = 2.05), and medical specialization (AOR = 1.663). Only 36.9% of females with PD sought formal medical advice. Most dysmenorrheic females (76.4%) received medications for the management of PD, and remarkably none of them took hormonal contraceptives. Drugs commonly used for PD were mefenamic acid (26.2%), ibuprofen (25%), and paracetamol (11.5%), which were administered when the pain started (58.2%). All medications were significantly effective in reducing the pain score (P = 0.001), and most NSAIDs were more potent than paracetamol in managing PD (P = 0.001). However, no significant difference in adverse effects among medications was revealed. Moreover, no superiority of any individual NSAID for pain relief was established. Nevertheless, mefenamic acid was associated with the lowest risk of abdominal pain (OR: 0.03, P = 0.005) and the highest risk of flank pain (OR = 12, P = 0.02).
CONCLUSIONS
Suboptimal management of PD is practiced among university students in Lebanon. Therefore, health care providers should educate dysmenorrheic females to optimize the self-management support of PD. Furthermore, future research is required to investigate females' misconceptions about hormonal contraceptives in the management of PD, aiming to raise awareness and correct misconceptions.
Topics: Cross-Sectional Studies; Dysmenorrhea; Female; Humans; Prevalence; Quality of Life; Risk Factors
PubMed: 34749716
DOI: 10.1186/s12905-021-01532-w -
Journal of the Formosan Medical... Aug 2022Taiwan Drug-Injury Relief System (TDRS) has been implemented since 1999. More than 60% of the approved applications were associated with severe cutaneous adverse...
BACKGROUND/PURPOSE
Taiwan Drug-Injury Relief System (TDRS) has been implemented since 1999. More than 60% of the approved applications were associated with severe cutaneous adverse reactions (SCARs). Studies assessing SCARs using real-world evidence are very limited. TDRS offers abundant case information as a source of real-world evidence to investigate the characteristics of SCARs in Taiwan. The purpose of this study is to understand the trends and characteristics of SCARs in Taiwan.
METHODS
Applications from Drug-Injury Relief Database (TDRD) from 1999 to 2016 were retrospectively analyzed.
RESULTS
A declining trend in SCARs application was noticed after 2012, and 952 applications of SCARs were identified. The most common subtypes of SCARs were SJS/TEN (n = 455/206), DRESS (n = 228), GBFDE (n = 34) and AGEP (n = 18). The most common culprit drugs were allopurinol, carbamazepine, phenytoin, diclofenac and lamotrigine for SJS/TEN; allopurinol, phenytoin, co-trimoxazole, carbamazepine and phenobarbital for DRESS; mefenamic acid for GBFDE; non-steroidal anti-inflammatory drugs (NSAIDs) and beta-lactam antibacterials for AGEP. The proportions of mortality cases were 28.9% for SJS/TEN; 36% for DRESS; 11.8% for GBFDE and 5.6% for AGEP. The mean latent period of SJS/TEN, DRESS, GBFDE and AGEP were 21.8 days, 29.2 days, 3.3 days and 6.7 days, respectively.
CONCLUSION
The approved drug-injury relief applications associated with SCARs were mainly SJS, TEN and DRESS. The most common culprit drugs were antiepileptics, antibacterials, antigout agents, and NSAIDs. The latent periods showed some distinct features for different types of SCARs. In light of the high mortality rate, public awareness and vigilance of SCARs are crucial for the patient safety.
Topics: Allopurinol; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Anticonvulsants; Carbamazepine; Cicatrix; Humans; Phenytoin; Retrospective Studies; Stevens-Johnson Syndrome; Taiwan
PubMed: 34674904
DOI: 10.1016/j.jfma.2021.09.025 -
Trials Sep 2021Primary dysmenorrhea (PD) is the most common complaint in young women and adolescents. Side effects of non-steroidal anti-inflammatory drugs can limit their use.... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Primary dysmenorrhea (PD) is the most common complaint in young women and adolescents. Side effects of non-steroidal anti-inflammatory drugs can limit their use. Therefore, non-pharmacological pain relief methods such as auriculotherapy may play an important role in PD management. This study was conducted to compare the effect of auriculotherapy and mefenamic acid on the severity and systemic symptoms of PD.
METHODS
In a randomized clinical trial, 83 students were randomized into two groups. In the auriculotherapy group, electrical stimulation of the ear was conducted once a week for two menstrual cycles. In each cycle close to menstruation, ear seeds were inserted on pressure points to be pressed in times of pain. In the mefenamic acid group, subjects took mefenamic acid capsules upon seeing the initial symptoms of menstruation until the pain reduces. The primary outcomes were mean pain intensity and systemic symptoms associated with it. Pain intensity was measured through the visual analog scale (VAS) and the verbal multidimensional scoring system (VMS). Systemic symptoms were assessed using VMS, as well as the yes/no question form.
RESULTS
Mean pain intensity with the VAS was significantly lower in the auriculotherapy group than the mefenamic acid group in the first and second cycles of intervention. There was a significant difference in VMS grade between both groups during the second cycle of intervention. In terms of the systemic symptoms in the second cycle of intervention, no subjects had dysmenorrhea grade 3 (common systemic symptoms) in the auriculotherapy group. Whereas in the mefenamic acid group, 16.7% of the subjects still had dysmenorrhea grade 3. There was no significant difference between the two groups in the frequency of systemic symptoms of PD. There was a significant decrease in the frequency of fatigue and diarrhea in both groups. However, there was a significant reduction in the frequency of nausea, headache, and anger in the auriculotherapy group.
CONCLUSION
Mean pain intensity with the VAS was lower with the auriculotherapy. Also, 65.9% of auriculotherapy group subjects were in the dysmenorrhea grades 0 and 1. Therefore, auriculotherapy is recommended because of its fewer complications and more effect on PD.
TRIAL REGISTRATION
ClinicalTrials.gov IRCT20181207041873N1. Registered on February 24, 2019. https://en.irct.ir/user/trial/35967/view.
Topics: Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Auriculotherapy; Dysmenorrhea; Female; Humans; Mefenamic Acid; Menstruation
PubMed: 34565433
DOI: 10.1186/s13063-021-05622-w