Delving into the Latest Updates on Simethicone with Synapse

Irritable bowel syndrome (IBS) is a functional gastrointestinal disease. There is no well-defined pharmacological treatment. This clinical trial is a prospective, double-blind, two-armed randomized controlled, single-center trial. It is created to examine the role of IBS in patients with lactose intolerance. IBS patients undergo lactose H2 breath test (LHBT) and lactose tolerance test (LTT). Those with positive LTT and LHBT will be randomized into two groups: alverine-citrate + simethicone and lactase group (1) or alverin-citrate + simethicone with the placebo group (2). The goal of this study is to compare the lactase enzyme with placebo in IBS patients with lactose intolerance.

Start Date01 Sep 2022

Sponsor / Collaborator

University of Pecs

100 Clinical Results associated with Simethicone

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100 Translational Medicine associated with Simethicone

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100 Patents (Medical) associated with Simethicone

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332

Literatures (Medical) associated with Simethicone

Clinical and translational gastroenterology

The Effect of Using Premedication of Simethicone/Pronase With or Without Postural Change on Visualization of the Mucosa Before Endoscopy: A Prospective, Double Blinded, Randomized Controlled Trial

Article

Author: Liu, Jingmei ; Wang, Deqiong ; Wang, Mi ; Zhou, Zhenzhen ; Liu, Mei ; Chen, Li ; Feng, Xinxia ; Zheng, Fangqin ; Guo, Qiaozhen ; Cao, Li

INTRODUCTION::

To investigate the efficacy and safety of preprocedural simethicone (S) and pronase (P) for optimal mucosal visualization during esophagogastroduodenoscopy with sedation. The effect of postural change combined with premedication on mucosal visibility was also examined.

METHODS::

The study randomized 496 patients into 8 groups based on the type of premedication provided and whether a postural change occurred. The premedication in the control group was 100 mL of normal saline solution (NS). The remaining 3 intervention groups were administered 100 mL of simethicone alone (S), pronase solution alone (P), and simethicone plus pronase solution (S + P). Each group was classified into subgroups according to whether there was a postural change (PC). The mucosal visibility score (MVS), total mucosal visibility score (TVS), procedure time, water consumption for mucosal cleansing, and proportion of patients with diminutive lesions <5 mm were recorded.

RESULTS::

The P and S groups had a significantly better TVS than the NS group (11.86 ± 3.36 in group P vs 14.52 ± 2.57 in group NS, P < 0.001; 12.36 ± 2.93 in group S vs 14.52 ± 2.57 in group NS, P = 0.006). The TVS was better in the P group than in the S group (11.86 ± 3.36 vs 12.36 ± 2.93, P = 0.037). The MVS was significantly better in the esophagus and duodenum and worse in the upper and lower gastric body in the S group than in the P group. The P + S group had a significantly better TVS than the P and S groups (9.81 ± 2.90 in group P + S vs 11.86 ± 3.36 in group P and 12.36 ± 2.93 in group S, respectively, P < 0.001),\ and had a reduced amount of flushing water during the procedure (0 [interquartile range [IQR]: 0–33] mL in group P + S vs 40 [IQR: 0–70] mL in group P, P < 0.01; 0 [IQR: 0–33] mL in group P + S vs 50 [IQR: 20–98] mL in group S, P < 0.001). The TVS was significantly better in the P + S + PC group than in the P + S group (8.44 ± 2.10 vs 9.81 ± 2.90, P = 0.003). The MVS was significantly better in the gastric antrum, fundus, and upper and lower gastric body in the P + S + PC group than in the P + S group. There was no significant difference in the detection rate of diminutive lesions among the different groups during an endoscopic examination (P > 0.05).

DISCUSSION::

The combination of preprocedural administration with simethicone and pronase achieved superior mucosal visualization compared with saline, simethicone, or pronase alone in patients receiving upper endoscopy. Postural change maneuvers performed before endoscopy further improved the mucosal visibility in most parts of the stomach when used with preprocedural simethicone and pronase.

01 Feb 2024·International journal of pharmaceutics

Drug-loaded vegan gummies for personalized dosing of simethicone: A feasibility study of semi-solid extrusion-based 3D printing of pectin-based low-calorie drug gummies

Article

Author: Ganatra, Pankti ; Jyothish, Lakshmi ; Sawant, Tanvi ; Mahankal, Vaishnavi ; Dandekar, Prajakta ; Jain, Ratnesh

Chewable gummies are an attractive dosage form for all age groups because of their appearance and texture. Although, this dosage form has been highly preferred administering nutraceuticals, its application in the pharmaceutical sector is worth exploring. In this study, simethicone (SMT), an OTC drug prescribed for anti-flatulence was incorporated in pectin- based, low-calorie, 3D printed gummies. Semi-solid extrusion (SSE)-based 3D printing was used to dispense personalized dose of SMT i.e 40 mg for children and 125 mg for adults. Formulation optimization was carried out based on the texture profile of the gummies, using a texture analyzer. The inks were thoroughly characterized for their rheological behavior since it is a critical attribute for SSE-based 3D printing. Printing parameters like the printing speed, layer height and the type of the nozzle were optimized based on the printing accuracy achieved. The printed gummies were further evaluated for their disintegration time, drug content, weight variation, water activity and total microbial count. SSE-based 3D printing was found to be an effective tool to print pectin-based shear thinning gels for accurate drug dispensing. The texture profile of the printed gummies was comparable to the gummies prepared by conventional method as well as the marketed samples.

01 Jan 2024·Digestive diseases and sciences

Efficacy and Safety of Pea Protein and Xyloglucan Versus Simethicone in Functional Abdominal Bloating and Distension

Article

Author: Dimitrova, Emiliya ; Petrisor, Diana Corina ; Santos, Javier ; Elenski, Kiril ; Etropolska, Zlatka

BACKGROUND:

Functional Abdominal Bloating and Distension (FABD) is a multifaceted condition related in part to trapped gas, with changes in the intestinal barrier and small intestinal bacterial overgrowth (SIBO), which lead to gas production. Currently, there are no treatments targeting the etiology of FABD.

METHODS:

This double-blind, multicenter, randomized study evaluated the safety and efficacy of a product containing xyloglucan and pea proteins (XG + PP) compared with simethicone, both administered orally (three times daily) for 20 consecutive days. Eighty-eight patients with FABD were randomly assigned to the two groups in a 1:1 ratio. Primary outcome was safety; secondary outcomes were (i) efficacy in alleviating the symptoms of FABD and (ii) efficacy in reducing SIBO, as assessed by hydrogen breath test (HBT).

RESULTS:

No Adverse Events or Serious Unexpected Adverse Reactions were reported during the study. XG + PP showed a faster onset of action and a significant reduction in bloating and abdominal pain compared with simethicone. At Day 20, XG + PP drastically reduced abdominal girth when compared with simethicone, with an average reduction of 4.7 cm versus 1.8 cm. At Day 20, the XG + PP arm showed a significant reduction in HBT compared to baseline.

CONCLUSIONS:

This study supports the evidence that FABD patients may benefit from a XG + PP-based treatment that acts on etiology and not just the symptoms.

1

News (Medical) associated with Simethicone

08 Apr 2024

·www.prnewswire.com

Wonderbelly Expands its Suite of Digestive Health Medicines with Launch of Bloat + Gas Relief

AUSTIN, Texas, April 8, 2024 /PRNewswire/ -- Wonderbelly, known for its effective digestive medicine, clean* ingredients and tasty flavors, today announced the launch of its latest product: Wonderbelly Bloat + Gas Relief. The launch marks a considerable milestone in Wonderbelly's goal to become the go-to brand for all things digestive health as the company grows into a second category of digestive medicine. Wonderbelly Bloat + Gas Relief is now available to consumers at Target, on Target.com and Amazon.com. Continue Reading Wonderbelly Expands its Suite of Digestive Health Medicines with Launch of Bloat + Gas Relief Post this Wonderbelly launches Bloat + Gas Relief in two delicious flavors, Strawberry Shortcake and Mango Smoothie. Wonderbelly products offer the same highly effective relief as leading medicine brands with a focus on clean ingredients that are Non-GMO and Clean Label Project Certified. Wonderbelly Bloat + Gas Relief has been expertly formulated to effectively combat symptoms like bloating, gas discomfort, abdominal pressure, and associated fullness. Boasting extra strength with 125mg of Simethicone, the company's new medicine comes in two enticing flavors: Strawberry Shortcake and Mango Smoothie. "From the very beginning, we've been committed to reimagining the digestive health experience so that people can feel good about feeling good. After launching Wonderbelly Antacid last year, we're thrilled to expand into a new digestive category to offer consumers highly effective bloat and gas relief in two delicious flavors we know people will love," says Wonderbelly founder Lucas Kraft. "Ultimately, Bloat + Gas represents a natural progression for Wonderbelly and a direct response to consumer demand for medicine that reflects their modern values. We've worked hard with our retail partners to identify customer needs and are proud to deliver a solution that gives them exactly what they're looking for." Building upon the success of Wonderbelly Antacid, which has rapidly become a consumer favorite with over one thousand five-star reviews, Wonderbelly Bloat + Gas Relief further cements Wonderbelly's role as a trailblazer in the rapidly evolving segment of modern digestive health medicine. "It's great to see Wonderbelly really resonate with consumer demand in the medicine space, particularly with trends towards clean ingredients and more sustainable packaging," says brain-gut expert Emeran Mayer, MD (emeranmayer.com). "I'm excited to continue to support Wonderbelly as they expand their offerings to provide relief for a range of digestive health symptoms." Wonderbelly is committed to using recyclable packaging, with bottles made solely of metal to reduce the use of plastic. Produced by one of the leading OTC manufacturers in the United States, Wonderbelly's products and novel packaging undergo rigorous testing, adhering to the stringent standards set for major pharmaceutical products. Wonderbelly can be found in Target and at retail locations across the country, like Wegmans, Meijer, Kroger, Fred Meyer, Fresh Thyme, Giant Eagle*, Raley's*, Harris Teeter, Central Market, Erewhon, Earth Fare, MOM's Organic. *Wonderbelly defines clean medicine as formulated using pharmaceutical active ingredients with inactive ingredients that are Clean Label Project-Certified, vegan, Non-GMO, and free of artificial dyes, artificial sweeteners, talc, titanium dioxide, parabens, gluten, and dairy. For more information about Wonderbelly, please visit Wonderbelly.com For visual assets, please see Dropbox PR Contact: [email protected] About Wonderbelly Wonderbelly™ is a digestive health medicine company founded by brothers Lucas and Noah Kraft. Wonderbelly makes effective and tasty digestive health medicine free from dyes, artificial sweeteners, talc, titanium dioxide, and genetically modified ingredients. Wonderbelly offers two products, Wonderbelly Antacid™ and Wonderbelly Bloat + Gas Relief™, in an assortment of delicious flavors. The company is committed to using recyclable packaging, including metal bottles and compostable on-the-go pouches, to reduce the use of plastic. SOURCE Wonderbelly

100 Deals associated with Simethicone

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Abdomen distended	US	-	01 Jan 1952
Flatulence	US	-	01 Jan 1952

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Abdominal Pain	Phase 3	RU	Abbott Laboratories	27 Nov 2020
Irritable Bowel Syndrome	Phase 3	RU	Abbott Laboratories	27 Nov 2020
Gastrointestinal Hemorrhage	Phase 1	US	Mayo Clinic	30 Apr 2010

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Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05175131 (CTgov)	Phase 3	Abdominal Pain \| Irritable Bowel Syndrome	465	Mebeverine+Simethicone (Mebeverine+Simethicone Combination)	aglnsrnaiu(rpdcnvmygk) = wwqxirkwsh wwwtuzsrsz (iywrsenrdu, phwpfmlxdj - kwcakpiahv) View more	-	03 Jan 2024
				Mebeverine (Mebeverine)	aglnsrnaiu(rpdcnvmygk) = qxrkjexxid wwwtuzsrsz (iywrsenrdu, kmwpkmtbra - zelcwgsbsh) View more
NCT03119168 (CTgov)	Phase 4	Adenoma	268	Simethicone Solution (Simethicone Solution + Polyethylenglycol)	bppyrdfeue(hfphklfrdt) = uzgyuqwqau cjnzhdkzqg (snqlvynwar, ojtxvsfmvn - powrnekvjx) View more	-	05 Jun 2019
				Polyethylenglycol (Polyethylenglycol)	bppyrdfeue(hfphklfrdt) = drfzrbxvuq cjnzhdkzqg (snqlvynwar, zniilwzlez - bxgriplvhg) View more
NCT02217982 (CTgov)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	5	Simethicone+Loperamide	gyqtmhrmgq(xlectdvwei) = jtjxhwvwbz ssgfeztrjx (eyguabevjx, iftmjfmjxx - yhofzajnvz) View more	-	06 Jan 2017
NCT01312038 (CTgov)	Phase 2	Functional disorder \| Otitis Media	25	Placebo (Placebo)	bzsuvdnqya(fgxiglalao) = exkxcrdvgk slyvwcgrux (qgpkffvidt, ynfjqaxwcf - ymfsokkncv) View more	-	27 Jun 2016
				Simethicone (Simethicone)	dfjixvoscc(ntarqojewj) = coqdrtnscy lbshejzebr (ygbfmuhvfz, repbfarqhe - ubhfjcdrlm) View more
NCT02555228 (CTgov)	Phase 2/3	Gastric mucosal lesion	54	Simethicone (Simethicone Premedication)	btmykcbwtz(fupzlqjrja) = rnlbqshzhj tgvzjzmtuc (htlllxulwx, vyczckzebi - kirntzowep) View more	-	15 Mar 2016
				Water (Placebo)	btmykcbwtz(fupzlqjrja) = mvsmttmejs tgvzjzmtuc (htlllxulwx, jsxhsvigev - daulkkcgnb) View more
NCT01653171 (Pubmed \| World J Gastroenterol)	Phase 4	-	230	Sodium phosphate plus simethicone	uairsbqovf(mpzzctxazf) = ssrmaeqlio ubttyrexbn (frnyoigani ) View more	-	28 Jun 2009
				Sodium phosphate plus placebo	uairsbqovf(mpzzctxazf) = qkactvakrp ubttyrexbn (frnyoigani ) View more
NCT01653171 (Pubmed \| J Zhejiang Univ Sci B)	Phase 4	Intestinal preparation	230	PEG solution	uelxhfwyhx(ercmkmyokw) = bazzqtdpre hzbkkphtuq (vboctmakni ) View more	-	01 Jan 2009
				PEG solution and simethicone	uelxhfwyhx(ercmkmyokw) = gwipxnqzqd hzbkkphtuq (vboctmakni ) View more