scholarly journals A robotic pill for oral delivery of biotherapeutics: safety, tolerability, and performance in healthy subjects

2021 ◽  
Author(s):  
Arvinder K. Dhalla ◽  
Ziad Al-Shamsie ◽  
Simret Beraki ◽  
Anvesh Dasari ◽  
Leonard C. Fung ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Oral Delivery ◽  
Gi Tract ◽  
Healthy Humans ◽  
Poor Patient Compliance ◽  
Balloon Size ◽  
Group A ◽  
Delivery Platform ◽  
And Performance ◽  
Group B

AbstractBiotherapeutics are highly efficacious, but the pain and inconvenience of chronic injections lead to poor patient compliance and compromise effective disease management. Despite innumerable attempts, oral delivery of biotherapeutics remains unsuccessful due to their degradation in the gastrointestinal (GI) environment and poor intestinal absorption. We have developed an orally ingestible robotic pill (RP) for drug delivery, which protects the biotherapeutic drug payload from digestion in the GI tract and auto-injects it into the wall of the small intestine as a safe, pain-free injection since the intestines are insensate to sharp stimuli. The payload is delivered upon inflation of a balloon folded within the RP, which deflates immediately after drug delivery. Here we present results from two clinical studies demonstrating the safety, tolerability and performance of the RP in healthy humans. In the first study, three versions of the RP (A, B and C) were evaluated, which were identical in all respects except for the diameter of the balloon. The RP successfully delivered a biotherapeutic (octreotide) in 3 out of 12 subjects in group A, 10 out of 20 subjects in group B and 16 out of 20 subjects in group C, with a mean bioavailability of 65 ± 9% (based on successful drug deliveries in groups A and B). Thus,  reliability of drug delivery with the RP ranged from 25 to 80%, with success rate directly related to balloon size. In a separate study, the deployment of the RP was unaffected by fed or fasting conditions suggesting that the RP may be taken with or without food. These promising clinical data suggest that biotherapeutics currently administered parenterally may be safely and reliably delivered via this versatile, orally ingestible drug delivery platform. Graphical abstract

scholarly journals Polymeric Micelles, a Promising Drug Delivery System to Enhance Bioavailability of Poorly Water-Soluble Drugs

2013 ◽  
Vol 2013 ◽  
pp. 1-15 ◽  
Author(s):  
Wei Xu ◽  
Peixue Ling ◽  
Tianmin Zhang
Keyword(s):  
Drug Delivery ◽  
Residence Time ◽  
Oral Delivery ◽  
Polymeric Micelles ◽  
Water Soluble ◽  
Gi Tract ◽  
Poorly Water Soluble Drugs ◽  
Water Soluble Drugs ◽  
Poorly Water Soluble ◽  
Accepted Form

Oral administration is the most commonly used and readily accepted form of drug delivery; however, it is find that many drugs are difficult to attain enough bioavailability when administered via this route. Polymeric micelles (PMs) can overcome some limitations of the oral delivery acting as carriers able to enhance drug absorption, by providing (1) protection of the loaded drug from the harsh environment of the GI tract, (2) release of the drug in a controlled manner at target sites, (3) prolongation of the residence time in the gut by mucoadhesion, and (4) inhibition of efflux pumps to improve the drug accumulation. To explain the mechanisms for enhancement of oral bioavailability, we discussed the special stability of PMs, the controlled release properties of pH-sensitive PMs, the prolongation of residence time with mucoadhesive PMs, and the P-gp inhibitors commonly used in PMs, respectively. The primary purpose of this paper is to illustrate the potential of PMs for delivery of poorly water-soluble drugs with bioavailability being well maintained.

Cognitive Function in Children With Idiopathic Subclinical Hypothyroidism: Effects of 2 Years of Levothyroxine Therapy

2020 ◽  
Vol 105 (3) ◽  
pp. e774-e781 ◽  
Author(s):  
Donatella Capalbo ◽  
Sara Alfano ◽  
Miriam Polizzi ◽  
Raffaella Di Mase ◽  
Nicola Improda ◽  
...  
Keyword(s):  
Subclinical Hypothyroidism ◽  
Therapy Group ◽  
Cognitive Domains ◽  
Group A ◽  
Iq Scores ◽  
And Performance ◽  
Group B ◽  
Control Prospective Study

Abstract Background Long-term consequences of mild subclinical hypothyroidism (SH) in children are still unclear, and the need for levothyroxine (L-T4) supplementation remains controversial. We designed a 2-year, case-control, prospective study of a cohort of children with SH to evaluate the effects of L-T4 therapy on neurocognitive outcome. Methods Thirty-four children, age 9.1 ± 2.6 years, with long-lasting, idiopathic, and mild SH, and 34 healthy matched controls, were enrolled. Twenty SH children underwent a 2-year L-T4 treatment (group A), whereas 14 refused treatment and were reevaluated after a 2-year-follow-up (group B). IQ and specific cognitive domains were evaluated in all children at study entry and after 2 years of therapy (group A) or observation (group B) in SH individuals. Results In SH children baseline IQ scores were normal and comparable to controls (full-scale IQ [FSIQ] 100.4 ± 11.3 vs 101.8 ± 14.2, verbal IQ [VIQ] 99.7 ± 13.7 vs 98.3 ± 14.9 and performance IQ [PIQ] 101.2 ± 10.4 vs 105 ± 10.4). In group A, L-T4 treatment was associated with normalization of thyrotropin (6.3 ± 1.0 mIU/L at baseline vs 2.8 ± 1.4 mIU/L at 2 years, P < .001). However, 2-year L-T4 therapy was not associated with a change in IQ scores (FSIQ 104.4 ± 13.8 vs 102.7 ± 11.0; VIQ 101.8 ± 14.9 vs 102.3 ± 11.9; and PIQ 106.5 ± 13.9 vs 102.7 ± 10.7) or in verbal or performance subtest scores. No significant differences were found in IQ scores after 2 years of treatment in group A compared to group B after a 2-year follow-up. Conclusions Our data suggest neurocognitive function in children is not impaired by persistent, mild, untreated SH and is not significantly modified by 2-year L-T4 supplementation.

scholarly journals Can preservative Nisin preserve periodontium?

2019 ◽  
pp. 21-24
Author(s):  
Rohit Shah ◽  
Rutuja Dhonde ◽  
Dipika Mitra ◽  
Silvia Rodrigues ◽  
Gaurav Shetty ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Test Group ◽  
Post Treatment ◽  
Local Drug Delivery ◽  
Clinical Parameters ◽  
Gingival Index ◽  
Root Planing ◽  
Group 15 ◽  
Group A ◽  
Group B

Brief Background: Nisin’ is found naturally in dairy products and is also used as a preservative in food and beverages. It shows a rapid and broad spectrum activity against both gram-negative and gram-positive bacteria and hence could be used as a local drug delivery agent. Aim: To evaluate the clinical efficacy (Gingival Index GI, Probing Pocket Depth PPD, (Relative Attachment level RAL) of Scaling Root Planing (SRP) alone versus SRP with Nisin gel as LDD in pocket reduction therapy at baseline and after 3 months. Methodology: 30 sites in patients with chronic periodontitis with 5-7mm PPD were selected after taking informed consent. It was a split mouth study. Sites were divided into Group A Test group (15 sites) treated with SRP + LDD of Nisin gel and Group B control group (15 sites) treated with SRP alone. Clinical parameters were recorded at baseline and post treatment at 3 months. Results: It was observed that there was an improvement in clinical parameters in both the groups from baseline to 3 months post treatment, with Group A Test Group showing superior results. There was statistically significant improvement in Gingival Index in Group A as compared to Group B. PPD and RAL did not show statistically significant difference in both the groups. Summary and Conclusions: Nisin improves periodontal health and hence can be potentially used as an LLD agent. Keywords: Nisin, Preservative, Local drug delivery, Scaling root planing.

scholarly journals TEAM-BASED LEARNING VS LECTURE-BASED LEARNING IN MEDICAL EDUCATION

2021 ◽  
pp. 5-6
Author(s):  
ASFIA IRFAN ◽  
SANA NAZ ◽  
ZAHID MEHMOOD ◽  
ZEHRA NASEEM ◽  
KANWAL NAZ ◽  
...  
Keyword(s):  
Medical Education ◽  
Medical Center ◽  
Control Program ◽  
P Value ◽  
Learning Methods ◽  
Medical Graduates ◽  
Team Based Learning ◽  
Group A ◽  
And Performance ◽  
Group B

Objective: The objective of the study is to determine better mode of learning for medical graduates by comparing team-based learning (TBL) and lecture-based learning methods. Study Design: Comparative analytical study. Place and Duration of Study: Surgical Ward 25 of Endocrine and General surgery, Jinnah Postgraduate Medical Center, Karachi, in April 2019. Methodology: This comparative study was based on the principles of TBL; the control program used the traditional lecture-based approach. Both programs were aimed at investigating the knowledge and performance of the two groups. Thirty surgical interns were included in this study. Two groups were made by random selection of surgical interns, 15 in TBL group and other 15 in traditional teaching group. TBL group (Group A) was given the topic of thyroid diseases for self-study followed by 1 h discussion amongst the group members. Lecture-based group (Group B) was given 1 h powerpoint presentation on similar topic. As the main outcome measures, questionnaire containing twenty best choice questions was given to both groups. Performance of the two groups was checked and results calculated as total, average, and standard deviation. Results: Group A participants’ total score (147) was higher than Group B (131) but the p-value was not found to be significant (0.144). Conclusion: Both forms of learning methods are effective and productive in medical education.

scholarly journals Impact of Age and Agility Performance Level on the Disjunctive Reaction Time of Soccer Goalkeepers

2019 ◽  
Vol 59 (2) ◽  
pp. 224-238
Author(s):  
Marco Obetko ◽  
Pavol Peráček ◽  
Peter Šagát ◽  
Martin Mikulič
Keyword(s):  
Reaction Time ◽  
Research Group ◽  
Research Data ◽  
Performance Level ◽  
Stimulus Difference ◽  
Group A ◽  
And Performance ◽  
Group B ◽  
The Impact ◽  
Reaction Speed

Summary The soccer goalkeeper's reaction speed to stimulus is essential for the overall success rate of goalkeepers in soccer. Our research was aimed at finding out the impact of age and agility performance level on the length of the disjunctive reaction time of elite goalkeepers in Slovakia. The research group was comprised of 24 goalkeepers of two Slovak soccer clubs (in group A were elite players and in group B sub-elite players). To gain the research data, the disjunctive reaction time was measured using the Fitro Agility Check device. The acquired results were statistically evaluated using the Mann-Whitney U-Test and Cohen's “d”. The impact of age (n.s) and performance level (n.s) on the length of the disjunctive reaction time of goalkeepers was not statistically confirmed. However, the substantive and logical significance showed that the best goalkeepers achieved a considerably shorter time of disjunctive reaction time to the set stimulus (difference – 20 %).

scholarly journals Assessment of the quality of life and performance status in patients with oral submucous fibrosis in central India

2018 ◽  
Vol 91 (2) ◽  
pp. 203-208
Author(s):  
Revant H. Chole ◽  
Ranjitkumar Patil
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Performance Status ◽  
Oral Submucous Fibrosis ◽  
European Organization ◽  
Group A ◽  
Submucous Fibrosis ◽  
And Performance ◽  
Group B

Background and aims. Measuring quality of life in patients with oral submucous fibrosis is of utmost importance in assessing treatment outcomes. This study examined the impact of oral submucous fibrosis and its treatment on the quality of life and performance status of persons with oral submucous fibrosis.Methods. Quality of life was measured in patients with oral submucous fibrosis using the European Organization for Research and Treatment of Cancer Quality of Life head and neck 35 Questionnaire (EORTC QLQ-C35); performance status was measured by Performance Status Scale for Head and Neck Cancer Patients (PSS-HN), at four points in time: baseline, one month, two months and three months after start of treatment.Results. At the end of third month Group A and Group B showed 78% and 85% increase in mouth opening respectively. While the burning sensation of oral mucosa was decreased by 72% and 88% in group A and group B respectively (Z>1.96, P<0.05), there were significant differences in patients' quality of life and functioning at three points in time (P < 0.05).Conclusion. The European Organization for Research and Treatment of Cancer Quality of Life head and neck 35 Questionnaire and Performance Status Scale for Head and Neck Cancer Patients can be used successfully in potentially malignant disorders like oral submucous fibrosis. The results in this study will surely be a good guide forother studies on oral submucous fibrosis.

scholarly journals Ecology and Genetic Lineages of Nasal Staphylococcus aureus and MRSA Carriage in Healthy Persons with or without Animal-Related Occupational Risks of Colonization: A Review of Global Reports

Pathogens ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 1000
Author(s):  
Idris Nasir Abdullahi ◽  
Carmen Lozano ◽  
Laura Ruiz-Ripa ◽  
Rosa Fernández-Fernández ◽  
Myriam Zarazaga ◽  
...  
Keyword(s):  
Nasal Carriage ◽  
Food Handlers ◽  
Genetic Lineages ◽  
Healthy Humans ◽  
Occupational Risks ◽  
Pooled Prevalence ◽  
Group A ◽  
Group B ◽  
English Articles ◽  
Group D

In this conceptual review, we thoroughly searched for appropriate English articles on nasal staphylococci carriage among healthy people with no reported risk of colonization (Group A), food handlers (Group B), veterinarians (Group C), and livestock farmers (Group D) published between 2000 and 2021. Random-effects analyses of proportions were performed to determine the pooled prevalence of S. aureus, MRSA, MRSA-CC398, and MSSA-CC398, as well as the prevalence of PVL-positive S. aureus from all eligible studies. A total of 166 eligible papers were evaluated for Groups A/B/C/D (n = 58/31/26/51). The pooled prevalence of S. aureus and MRSA in healthy humans of Groups A to D were 15.9, 7.8, 34.9, and 27.1%, and 0.8, 0.9, 8.6, and 13.5%, respectively. The pooled prevalence of MRSA-CC398 nasal carriage among healthy humans was as follows: Group A/B (<0.05%), Group C (1.4%), Group D (5.4%); and the following among Group D: pig farmers (8.4%) and dairy farmers (4.7%). The pooled prevalence of CC398 lineage among the MSSA and MRSA isolates from studies of the four groups were Group A (2.9 and 6.9%), B (1.5 and 0.0%), C (47.6% in MRSA), and D (11.5 and 58.8%). Moreover, MSSA-CC398 isolates of Groups A and B were mostly of spa-t571 (animal-independent clade), while those of Groups C and D were spa-t011 and t034. The MRSA-CC398 was predominately of t011 and t034 in all the groups (with few other spa-types, livestock-associated clades). The pooled prevalence of MSSA and MRSA isolates carrying the PVL encoding genes were 11.5 and 9.6% (ranges: 0.0–76.9 and 0.0–28.6%), respectively. Moreover, one PVL-positive MSSA-t011-CC398 isolate was detected in Group A. Contact with livestock and veterinary practice seems to increase the risk of carrying MRSA-CC398, but not in food handlers. Thus, this emphasizes the need for integrated molecular epidemiology of zoonotic staphylococci.

scholarly journals A distance education experience on assessment of airway maneuvers during COVID-19 pandemic

2021 ◽  
Vol 15 (1) ◽  
pp. 1-8
Author(s):  
M Murat Oktay ◽  
Mustafa Boğan ◽  
Mustafa Sabak ◽  
Hasan Gümüşboğa ◽  
İbrahim Bilir ◽  
...  
Keyword(s):  
Distance Education ◽  
Head Tilt ◽  
Performance Measurements ◽  
Face To Face ◽  
Education Experience ◽  
Practical Education ◽  
Group A ◽  
And Performance ◽  
Group B ◽  
Jaw Thrust Maneuver

Background and objectives: The coronavirus disease 2019 (COVID-19) pandemic has necessitated the switch to distance education by abandoning face-to-face education worldwide. This study aimed to investigate whether it is possible for practical education and performance measurements through distance education. Methods: The application video and the application steps were sent to the participants through their smartphone by WhatsApp messenger. Grade 1 students in the Physiotherapy Section (Group A) and Grade 1 students in the Paramedic Section (Group B) voluntarily participated in the study. The participants were asked to apply simulation applications and record the simulation applications' video clips with their smartphones. Results: The mean age of the 123 participants was 20.11 ± 2.03 (18-33) years, and 56 (45.5%) were in Group A, and 67 (54.5%) were in Group B. While the participants in Group A were successful at a rate of 35.7% (n = 20) in the head tilt-chin lift maneuver, this rate was 65.7% (n = 44) for Group B (p = 0.001). For the jaw thrust maneuver, the success rate was 21.4% (n = 12) for Group A and 31.3% (n = 21) for Group B. Conclusion: In this study, the participants used family members as a live simulation model in our research. The participants who were given face-to-face education before were more successful on head tilt chin lift maneuver. Jaw thrust maneuver was more challenging to learn and practice by distance education. The academicians interested in medical education should keep in mind that the outcomes of the COVID-19 pandemic have permanent effects on education systems. Ibrahim Med. Coll. J. 2021; 15(1): 1-8

An ultrastructural study of sertoli cells in two geographically isolated populations of Aphanius dispar

1992 ◽  
Vol 50 (1) ◽  
pp. 548-549
Author(s):  
Taber A. Ba-Omar ◽  
Philip F. Prentis
Keyword(s):  
Ultrastructural Level ◽  
Uranyl Acetate ◽  
Freshwater Teleost ◽  
Isolated Populations ◽  
En Bloc ◽  
The North ◽  
Group A ◽  
Ultrathin Sections ◽  
Group B ◽  
Geographically Isolated

We have recently carried out a study of spermiogenic differentiation in two geographically isolated populations of Aphanius dispar (freshwater teleost), with a view to ascertaining variation at the ultrastructural level. The sampling areas were the Jebel Al Akhdar in the north (Group A) and the Dhofar region (Group B) in the south. Specimens from each group were collected, the testes removed, fixed in Karnovsky solution, post fixed in OsO, en bloc stained with uranyl acetate and then routinely processed to Agar 100 resin, semi and ultrathin sections were prepared for study.

Comparison of one-year prognosis of patients classified as chronic critical lower limb ischaemia according to TASC II or European consensus definition in the COPART cohort

VASA ◽  
2015 ◽  
Vol 44 (3) ◽  
pp. 0220-0228 ◽  
Author(s):  
Marion Vircoulon ◽  
Carine Boulon ◽  
Ileana Desormais ◽  
Philippe Lacroix ◽  
Victor Aboyans ◽  
...  
Keyword(s):  
Medical Treatment ◽  
Critical Limb Ischaemia ◽  
Limb Ischaemia ◽  
Medical Group ◽  
Consensus Definition ◽  
Transcutaneous Oxygen ◽  
European Consensus ◽  
Group A ◽  
One Year ◽  
Group B

Background: We compared one-year amputation and survival rates in patients fulfilling 1991 European consensus critical limb ischaemia (CLI) definition to those clas, sified as CLI by TASC II but not European consensus (EC) definition. Patients and methods: Patients were selected from the COPART cohort of hospitalized patients with peripheral occlusive arterial disease suffering from lower extremity rest pain or ulcer and who completed one-year follow-up. Ankle and toe systolic pressures and transcutaneous oxygen pressure were measured. The patients were classified into two groups: those who could benefit from revascularization and those who could not (medical group). Within these groups, patients were separated into those who had CLI according to the European consensus definition (EC + TASC II: group A if revascularization, group C if medical treatment) and those who had no CLI by the European definition but who had CLI according to the TASC II definition (TASC: group B if revascularization and D if medical treatment). Results: 471 patients were included in the study (236 in the surgical group, 235 in the medical group). There was no difference according to the CLI definition for survival or cardiovascular event-free survival. However, major amputations were more frequent in group A than in group B (25 vs 12 %, p = 0.046) and in group C than in group D (38 vs 20 %, p = 0.004). Conclusions: Major amputation is twice as frequent in patients with CLI according to the historical European consensus definition than in those classified to the TASC II definition but not the EC. Caution is required when comparing results of recent series to historical controls. The TASC II definition of CLI is too wide to compare patients from clinical trials so we suggest separating these patients into two different stages: permanent (TASC II but not EC definition) and critical ischaemia (TASC II and EC definition).

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