Commercially Available Enteric Empty Hard Capsules, Production Technology and Application

Franc, Aleš; Vetchý, David; Fülöpová, Nicole

doi:10.3390/ph15111398

Cited by 14 publications

(10 citation statements)

References 63 publications

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“…A "pure" placebo is typically represented by empty capsules (Welzel et al, 2021;Tsaturyan et al, 2023;Franc et al, 2022;Moerbeek, 2023) or inert substances like starch, dextromaltose, lactose, talc, mentholated water, and saline (Mitsikostas et al, 2020). The diversity of placebo effects is attributed to various biological mechanisms, influenced by the evolutionary development of the body's unique defense mechanisms (Benedetti, 2014;Buergler et al, 2023;Seneviratne et al, 2022;Pronovost-Morgan et al, 2023).…”

Section: Discussionmentioning

confidence: 99%

Placebo-resistant gut bacteria: Akkermansia muciniphila spp. and Familial Mediterranean fever disease

Pepoyan,

Marotta,

Manvelyan

et al. 2024

Front. Cell. Infect. Microbiol.

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IntroductionDespite numerous investigations into the impact of drugs/probiotics on the gut microbiota composition in Familial Mediterranean Fever (FMF) patients, the question as to whether there exists a significant bacterial diversity(ies) independent of the placebo effect that can be reliably considered in clinical and nutritional trials remains unresolved.MethodsThis study represents the in augural analysis of the placebo’s influence on the gut microbiota of both healthy individuals and FMF afflicted men, utilizing previously collected data from PhyloChip™ DNA microarray experiments. A total of 15 healthy and 15 FMF male volunteers, aged 18 to 50, participated in this partially randomized placebo trial, which is accessible through the GEO Series accession number GSE111835.Results and DiscussionKey findings from current investigations include i. the anticipated divergence in gut bacteria resistance to placebo between healthy and FMF individuals, ii. the minor impact of placebo on gut bacterial diversities in healthy individuals, with Enterobacteriaceae diversities identified as placebo-resistant among “healthy” gut bacteria, and iii. the comprehensive influence of placebo on all bacterial phyla in the gut microbiome of FMF patients, extending to nearly all bacterial genera, except for the resilience of gut Akkermansia muciniphila spp. to placebo in FMF patients. This study underscores the susceptibility of Faecalibacterium, Blautia, and Clostridium genera to placebo. Consequently, this investigation holds significance for the proper design of placebo-controlled trials and establishes a foundation for further exploration of the gut-brain axis. Furthermore, it contributes valuable insights to discussions regarding proposals for probiotic therapies, particularly focusing on Faecalibacterium spp., Blautia spp., and Clostridium spp.

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Section: Discussionmentioning

confidence: 99%

Placebo-resistant gut bacteria: Akkermansia muciniphila spp. and Familial Mediterranean fever disease

Pepoyan,

Marotta,

Manvelyan

et al. 2024

Front. Cell. Infect. Microbiol.

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“…In contrast, in IBS, FMT administered via upper or lower endoscopy, rather than capsules, has resulted in significant improvements in IBS-SSS. While much research has focused on FMT capsules[ 79 ], it is possible that the engraftment of the donor microbiota is better accomplished through endoscopic methods in IBS patients. Future RCTs in IBS patients that examines the combination of different routes of delivery for strain engraftment could be very interesting.…”

Section: Discussionmentioning

confidence: 99%

Fecal microbiota transplantation for the treatment of irritable bowel syndrome: A systematic review and meta-analysis

Halkjær¹,

Lo²,

Cold³

et al. 2023

World J Gastroenterol

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BACKGROUND Irritable bowel syndrome (IBS) is the most prevalent gastrointestinal disorder in developed countries and reduces patients’ quality of life, hinders their ability to work, and increases health care costs. A growing number of trials have demonstrated an aberrant gut microbiota composition in IBS, also known as ‘gut dysbiosis’. Fecal microbiota transplantation (FMT) has been suggested as a treatment for IBS. AIM To assess the efficacy and safety of FMT for the treatment of IBS. METHODS We searched Cochrane Central, MEDLINE, EMBASE and Web of Science up to 24 October 2022 for randomised controlled trials (RCTs) investigating the effectiveness of FMT compared to placebo (including autologous FMT) in treating IBS. The primary outcome was the number of patients with improvements of symptoms measured using a validated, global IBS symptoms score. Secondary outcomes were changes in quality-of-life scores, non-serious and serious adverse events. Risk ratios (RR) and corresponding 95%CI were calculated for dichotomous outcomes, as were the mean differences (MD) and 95%CI for continuous outcomes. The Cochrane risk of bias tool was used to assess the quality of the trials. GRADE criteria were used to assess the overall quality of the evidence. RESULTS Eight RCTs (484 participants) were included in the review. FMT resulted in no significant benefit in IBS symptoms three months after treatment compared to placebo (RR 1.19, 95%CI: 0.68-2.10). Adverse events were reported in 97 participants in the FMT group and in 45 participants in the placebo group (RR 1.17, 95%CI: 0.63-2.15). One serious adverse event occurred in the FMT group and two in the placebo group (RR 0.42, 95%CI: 0.07-2.60). Endoscopic FMT delivery resulted in a significant improvement in symptoms, while capsules did not. FMT did not improve the quality of life of IBS patients but, instead, appeared to reduce it, albeit non significantly (MD -6.30, 95%CI: -13.39-0.79). The overall quality of the evidence was low due to moderate-high inconsistency, the small number of patients in the studies, and imprecision. CONCLUSION We found insufficient evidence to support or refute the use of FMT for IBS. Larger trials are needed.

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“…[7] To simplify the procedure, efforts have been made to develop oral formulations such as frozen fecal bacterial suspensions that are encapsulated in two successive capsules. [8][9][10] Unfortunately, commercial enteric capsules such as DRcaps and Vcaps Enteric, which are mainly derived from hydroxypropyl methylcellulose (HPMC), [11] cannot withstand aqueous media for long periods. [12] Consequently, attempts have been made to dry the suspensions but have resulted in a loss in viability.…”

Section: Introductionmentioning

confidence: 99%

Colonic Delivery of Aqueous Suspensions Using 3D Printed Capsules

Green Buzhor,

Abdi,

Luo

et al. 2024

Adv Materials Technologies

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The efficient oral delivery of aqueous suspensions to the distal intestine or the colon is a significant pharmaceutical challenge because few capsules are sufficiently stable to protect aqueous suspensions while enduring the conditions during gastrointestinal (GI) transit. Herein, a design is introduced for enteric capsules intended to transport aqueous media to the distal part of the intestine. These capsules consist of a water‐insoluble body and lid that encapsulate the solution and are held together by an enteric water‐soluble locking cap. The capsules are fabricated using a combination of 3D printing methods enabling design control and precision. Mechanical testing reveals that the capsules are soft, strong, and could withstand forces generally encountered during GI transit. The capsules also exhibit resistance to proton diffusion, which is important for protecting their content from gastric acidity. In vitro dissolution assessments and in vivo imaging studies demonstrate that the capsules release their content in the later stages of the GI tract. This unique design has potential applications in targeted delivery of aqueous suspensions of live bacterial suspensions to the colon, offering a promising platform for therapeutic interventions and research in gut health.

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Commercially Available Enteric Empty Hard Capsules, Production Technology and Application

Cited by 14 publications

References 63 publications

Placebo-resistant gut bacteria: Akkermansia muciniphila spp. and Familial Mediterranean fever disease

Placebo-resistant gut bacteria: Akkermansia muciniphila spp. and Familial Mediterranean fever disease

Fecal microbiota transplantation for the treatment of irritable bowel syndrome: A systematic review and meta-analysis

Colonic Delivery of Aqueous Suspensions Using 3D Printed Capsules

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