Ingestibility and Formulation Quality of Lansoprazole Orally Disintegrating Tablets

Objectives. We evaluated the ingestibility and formulation quality of one branded (formulation A) and five generic (formulations B, C, D, E, and F) lansoprazole orally disintegrating (OD) tablets. Methods. Ingestibility, including the oral disintegrating time, taste, mouth feeling, and palatability, was examined by sensory testing in healthy subjects. Formulation qualities, including salivary stability, gastric acid resistance, and intestinal dissolution behavior, were examined. Results and Discussion. The oral disintegration time of formulation F (52 s) was significantly longer than that of other formulations (32–37 s). More than 90% of subjects did not experience bitterness with formulations A, E, and F, whereas 50% of subjects felt rough and powdery sensations with formulations B, C, and D. More than 80% of subjects suggested that formulations A, E, and F had good palatability. Ingestibility was different between formulations. OD tablets consist of enteric granules containing lansoprazole, which is unstable in gastric acid. Enteric granules of each formulation were stable in artificial saliva and gastric juice. No differences were observed in dissolution behaviors among the formulations, indicating that the formulation quality of the formulations was almost equivalent. Conclusions. This study provides useful information for selecting branded or generic lansoprazole OD tablets for individualized treatments.

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Statistical assessment of in vitro drug release kinetics and quality evaluation of desloratadine orally disintegrating generic tablets available in Bangladesh

Journal of Generic Medicines The Business Journal for the Generic Medicines Sector ◽

10.1177/1741134320947750 ◽

2020 ◽

pp. 174113432094775

Author(s):

Madhabi Lata Shuma ◽

Shimul Halder

Keyword(s):

Release Kinetics ◽

The United States ◽

Quality Parameters ◽

In Vitro Dissolution ◽

Dissolution Behavior ◽

Dissolution Profile ◽

Disintegration Time ◽

In Vitro Drug Release ◽

Orally Disintegrating Tablets

The objective of the present study was to compare the in vitro equivalence of different orally disintegrating tablets (ODT) of Desloratadine (DES) available in Bangladesh pharmaceutical market with the reference brand. The in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method and a comparative study were also carried out with the reference brand. Other pharmacopoeial and non-pharmacopoeial quality assessment parameters including hardness, friability, water absorption ratio, and disintegration time etc. were also evaluated. From the results of the dissolution profile of the commercially available products, it found majority of the products didn’t exhibited compendial requirements in dissolution behavior to the reference brand with model-independent approach ( f2 > 50, f1 < 15) and showed statistically significant differences. Additionally, the data of different physical quality parameters revealed that all commercial products complied with the official specifications. From these findings, it could be suggested that the DES-ODT formulations’ available in the Bangladesh market could be prescribed; however additional experiments might require to clarify the interchangeability among the products.

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Physicochemical qualities and ingestibility of high value-added amlodipine besilate formulations

Journal of Generic Medicines The Business Journal for the Generic Medicines Sector ◽

10.1177/1741134316673225 ◽

2016 ◽

Vol 13 (1) ◽

pp. 28-33 ◽

Cited By ~ 3

Author(s):

Sumio Chono ◽

Eno Yamada ◽

Megumi Matsui ◽

Takuma Sato ◽

Ryoya Kasai

Keyword(s):

Oral Cavity ◽

Healthy Subjects ◽

Value Added ◽

Sensory Characteristics ◽

Brand Name ◽

Disintegration Time ◽

Orally Disintegrating Tablets ◽

Tablet Strength ◽

Wetting Time ◽

Film Formulation

Objectives The physicochemical qualities and ingestibility of high value-added amlodipine besilate formulations were evaluated using one brand name and four generic orally disintegrating tablets (formulations A, B, C, D, and E) and a generic orally disintegrating film (formulation F). Methods Pushing out from a press-through package, tablet strength, and hydrophilia were examined for the aforementioned formulations A–E, and sensory characteristics according to the disintegration time, taste, and palatability in healthy subjects were evaluated for formulations A–F. Results The strength required for pushing out from a press-through package for formulations A, B, C, D, and E was approximately 20 N, indicating ease of opening for most users. Moreover, hardness and friability of formulations A, B, C, D, and E were more than 0.03 kg/mg and less than 1%, respectively. Thus, all formulations had sufficient tablet strength to endure fall impact in the automatic packing machine and vibration when carrying them from one place to another. The wetting time of formulation E (9 s) was significantly shorter than that of formulations A (27 s), B (34 s), C (28 s), and D (29 s), indicating that with the exception of hydrophilia, the physicochemical qualities of the five aforementioned formulations of orally disintegrating tablets were equivalent. The disintegration time of formulations E (15 s) and F (15 s) in the oral cavity was significantly shorter than that of formulations A (23 s), B (26 s), C (25 s), and D (22 s). Moreover, more than 50% of subjects reported strong or weak bitterness for formulations B, C, D, E, and F. Finally, more than 80% of subjects described formulations A, E, and F as easy to take, indicating good palatability. Conclusions This study provides useful information for selecting high value-added amlodipine besilate formulations for individualized treatments.

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Circadian Rhythm of Gastric Acid Secretion in Active Duodenal Ulcer: Chronobiological Statistical Characteristics and Comparison of Acid Secretory and Plasma Gastrin Patterns with Healthy Subjects and Post-Vagotomy and Pyloroplasty Patients

Chronobiology International ◽

10.3109/07420528709078513 ◽

1987 ◽

Vol 4 (1) ◽

pp. 101-110 ◽

Cited By ~ 3

Author(s):

John Moore ◽

Franz Halberg

Keyword(s):

Duodenal Ulcer ◽

Circadian Rhythm ◽

Acid Secretion ◽

Gastric Acid Secretion ◽

Gastric Acid ◽

Healthy Subjects ◽

Statistical Characteristics ◽

Plasma Gastrin

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Formulation and Evaluation of Baclofen Orally Disintegrating Tablets

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2009.2.4.7 ◽

1970 ◽

Vol 2 (4) ◽

pp. 733-738

Author(s):

Dumpeti Janardhan ◽

Joginapally Sreekanth ◽

P.Theja Pavan Kumar ◽

M.Vamshi Krishna

Keyword(s):

Pilot Scale ◽

Taste Masking ◽

Wet Granulation ◽

Physical Parameters ◽

Disintegration Time ◽

Granulation Process ◽

Good Taste ◽

Orally Disintegrating Tablets ◽

Human Volunteers ◽

Eudragit Epo

The purpose of this study was to evaluate the potential of polymers for masking the taste of bitter drugs when incorporated into orally disintegrating tablets. The tablets were produced by simple wet granulation technique with a model compound (baclofen) which is moderately bitter. The formulating procedure had two variables to obtain good taste masking with desirable characteristics. The optimal granulation process parameters were polymer selection and its concentration (w/w), suitable for pilot scale level. Dextrates, β- cyclodextrin, eudragit EPO and PVP K-30 were used in preparation of granules by using water and iso-propyl alcohol. Crospovidone was used intra and extra granularly as superdisintegrant. Sodium bicarbonate and citric acid were used as effervescent for fast disintegration of tablets, which also optionally act as desensitizer of taste buds. Results from evaluation of tablets indicated a disintegration time (avg) of 30-35 sec and 100% drug release was achieved within 5 min. But taste masking was achieved by only with eudragit EPO. Results from an evaluation by a panel of six human volunteers demonstrated that the orally disintegrating tablets which are prepared by using polymer Eudragit EPO (5% and 7.5% w/w of tablet) and PVP (7.5% w/w of tablet) improved taste, significantly. On studying physical parameters, F9 formulation demonstrated acceptable level of hardness and friability with good taste masking and it was thus considered as an optimized formulation

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SWE and SMI ultrasound techniques for monitoring needling treatment of ankylosing spondylitis: study protocol for a single-blinded randomized controlled trial

Trials ◽

10.1186/s13063-021-05344-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Mengyu Wang ◽

Wen Fu ◽

Lingcui Meng ◽

Jia Liu ◽

Lihua Wu ◽

...

Keyword(s):

Quality Of Life ◽

Blood Flow ◽

Ankylosing Spondylitis ◽

Outcome Measures ◽

Healthy Subjects ◽

Acupuncture Group ◽

Musculoskeletal Ultrasound ◽

Sham Control ◽

Post Intervention

Abstract Background Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL). It is often accompanied by arthralgia, stiffness, and limited lumbar flexibility. Acupuncture is safe and effective for reducing the symptoms of AS, but the underlying mechanisms by which it does so are not fully understood. Therefore, to objectively assess acupuncture efficacy, which is critical for patients making informed decisions about appropriate treatments, we will use shear-wave elastography (SWE) and superb microvascular imaging (SMI) ultrasound techniques to evaluate elasticity of lumbar paraspinal muscles and blood flow to the sacroiliac joint (SIJ) in AS. Methods We will recruit a total of 60 participants diagnosed with AS and 30 healthy subjects. Participants will be randomly allocated 1:1 to either an acupuncture group or a sham control acupuncture group. Primary-outcome measures will be musculoskeletal ultrasound, Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Metrology Index (BASMI), and the Visual Analogue Scale (VAS) for pain. Secondary outcome measures will be the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Function Index (BASFI), and Fatigue Scale-14 (FS-14). We will monitor the effect of acupuncture or sham acupuncture on blood flow and SIJ inflammation using SMI, lumbar-muscle stiffness using SWE and the lumbar paraspinal-muscle cross-sectional area (CSA) using a two-dimensional (2D) grayscale imaging. QoL, physical function, and fatigue will be assessed using an evaluation scale or questionnaire developed for this study, with outcomes measured by the ASQoL, BASMI, BASDAI, BASFI, and FS-14. Healthy subjects will not receive acupuncture but undergo only musculoskeletal ultrasound at baseline. Acupuncture and sham control acupuncture interventions will be conducted for 30 min, 2–3 times/week for 12 weeks. Musculoskeletal ultrasound will be conducted at baseline and post-intervention, while other outcomes will be measured at baseline, 6 weeks, and post-intervention. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Discussion The results of this single-blinded, randomized trial with sham controls could help demonstrate the efficacy of acupuncture and clarify whether musculoskeletal ultrasound could be used to evaluate AS. Trial registration ClinicalTrials.gov ChiCTR2000031476. Registered 3 April 2020.

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Critical appraisal and meta-analysis of biological variation studies on glycosylated albumin, glucose and HbA1c

Advances in Laboratory Medicine / Avances en Medicina de Laboratorio ◽

10.1515/almed-2020-0029 ◽

2020 ◽

Vol 1 (3) ◽

Author(s):

Carmen Ricós ◽

Pilar Fernández-Calle ◽

Elisabet Gonzalez-Lao ◽

Margarida Simón ◽

Jorge Díaz-Garzón ◽

...

Keyword(s):

Healthy Subjects ◽

Critical Appraisal ◽

Meta Analysis ◽

Biological Variation ◽

Evidence Based ◽

Literature Searches ◽

Variation Data ◽

Global Estimates ◽

Systematic Literature Searches

AbstractObjectivesNumerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA1c, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).MethodsSystematic literature searches were performed to identify BV studies. Nine publications not included in a previous review were identified; four for glycosylated albumin, three for glucose, and three for HbA1c. Relevant studies were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Global BV estimates were derived by meta-analysis of BIVAC-compliant studies in healthy subjects with similar study design.ResultsOne study received BIVAC grade A, 2B, and 6C. In most cases, the C-grade was associated with deficiencies in statistical analysis. BV estimates for glycosylated albumin were: CVI=1.4% (1.2–2.1) and CVG=5.7% (4.7–10.6), whereas estimates for HbA1c, CVI=1.2% (0.3–2.5), CVG=5.4% (3.3–7.3), and glucose, CVI=5.0% (4.1–12.0), CVG=8.1% (2.7–10.8) did not differ from previously published global estimates.ConclusionsThe critical appraisal and rating of BV studies according to their methodological quality, followed by a meta-analysis, generate robust, and reliable BV estimates. This study delivers updated and evidence-based BV estimates for glycosylated albumin, glucose and HbA1c.

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Gut microbiota profiles and characterization of cultivable fungal isolates in IBS patients

Applied Microbiology and Biotechnology ◽

10.1007/s00253-021-11264-4 ◽

2021 ◽

Author(s):

Piero Sciavilla ◽

Francesco Strati ◽

Monica Di Paola ◽

Monica Modesto ◽

Francesco Vitali ◽

...

Keyword(s):

Candida Albicans ◽

Gut Microbiota ◽

Healthy Subjects ◽

Fungal Isolates ◽

Key Points ◽

Health Promoting ◽

Irritable Bowel

Abstract Studies so far conducted on irritable bowel syndrome (IBS) have been focused mainly on the role of gut bacterial dysbiosis in modulating the intestinal permeability, inflammation, and motility, with consequences on the quality of life. Limited evidences showed a potential involvement of gut fungal communities. Here, the gut bacterial and fungal microbiota of a cohort of IBS patients have been characterized and compared with that of healthy subjects (HS). The IBS microbial community structure differed significantly compared to HS. In particular, we observed an enrichment of bacterial taxa involved in gut inflammation, such as Enterobacteriaceae, Streptococcus, Fusobacteria, Gemella, and Rothia, as well as depletion of health-promoting bacterial genera, such as Roseburia and Faecalibacterium. Gut microbial profiles in IBS patients differed also in accordance with constipation. Sequence analysis of the gut mycobiota showed enrichment of Saccharomycetes in IBS. Culturomics analysis of fungal isolates from feces showed enrichment of Candida spp. displaying from IBS a clonal expansion and a distinct genotypic profiles and different phenotypical features when compared to HS of Candida albicans isolates. Alongside the well-characterized gut bacterial dysbiosis in IBS, this study shed light on a yet poorly explored fungal component of the intestinal ecosystem, the gut mycobiota. Our results showed a differential fungal community in IBS compared to HS, suggesting potential for new insights on the involvement of the gut mycobiota in IBS. Key points • Comparison of gut microbiota and mycobiota between IBS and healthy subjects • Investigation of cultivable fungi in IBS and healthy subjects • Candida albicans isolates result more virulent in IBS subjects compared to healthy subjects

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Isokinetic Trunk Strength in Acute Low Back Pain Patients Compared to Healthy Subjects: A Systematic Review

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052576 ◽

2021 ◽

Vol 18 (5) ◽

pp. 2576

Author(s):

Waleska Reyes-Ferrada ◽

Luis Chirosa-Rios ◽

Angela Rodriguez-Perea ◽

Daniel Jerez-Mayorga ◽

Ignacio Chirosa-Rios

Keyword(s):

Systematic Review ◽

Low Back Pain ◽

Back Pain ◽

Reference Values ◽

Healthy Subjects ◽

Isokinetic Strength ◽

Low Back ◽

Acute Low Back Pain ◽

Trunk Strength

Background: The purpose of this systematic review was to: (I) determine the quality of evidence from studies assessing trunk isokinetic strength in subjects with acute low back pain (ALBP) compared to healthy subjects and (II) establish reference values of isokinetic trunk strength in subjects with ALBP. Methodology: Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statements were followed using keywords associated with trunk, strength and low back pain. Four databases were used: PubMed, Web of Science, Scopus and SPORTDiscus. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS). Results: A total of 1604 articles were retrieved, four included in this review. All were evaluated as high risk of bias (Rob). Due to the high Rob and the diversity of protocols, instruments and variables used, it was not possible to determine reference values for subjects with ALBP, we can only establish a range of flexion peak torque (PT) between 175.1 and 89.7 Nm at 60°/s and between 185 and 81.5 Nm at 120°/s, and for extension PT between 240.0 and 91.5 Nm at 60°/s and between 217.5 and 69.2 Nm at 120°/s in subjects with ALBP. Conclusions: Due to the low quality of the evidence and the diversity of protocols used when measuring trunk isokinetic strength, it is necessary to carry out new high-quality research to establish reference values of trunk strength in subjects with ALBP.

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A Pilot Study: Application of Hemoglobin and Cortisol Levels, and A Memory Test to Evaluate the Quality of Life of Breast Cancer Patients on Chemotherapy

The International Journal of Biological Markers ◽

10.5301/jbm.5000053 ◽

2013 ◽

Vol 28 (4) ◽

pp. 348-356 ◽

Cited By ~ 1

Author(s):

Wings TY Loo ◽

Michael CW Yip ◽

Louis WC Chow ◽

Qing Liu ◽

Elizabeth LY Ng ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Cancer Patients ◽

Blood Cells ◽

Healthy Subjects ◽

Short Term Memory ◽

White Blood Cells ◽

Breast Cancer Patients ◽

Cortisol Levels

Background Short-term memory (STM) decline in breast cancer patients resulting from chemotherapy was evaluated by means of blood biomarkers, a questionnaire, and a computerized STM test. Methods This study was conducted from January 2013 to June 2013, recruiting 90 subjects: 30 breast cancer patients beginning the 3rd of 4th cycles of docetaxel and cyclophosphamide chemotherapy, 30 recovered patients (who completed 4 cycles of docetaxel for a minimum of 6 months), and 30 healthy subjects (disease-free females). The levels of hemoglobin, red and white blood cells, and cortisol in serum, and a computerized STM test were analyzed to estimate the effects of chemotherapy on STM. A questionnaire was given to all subjects to assess quality of life. Results Statistically significant differences were observed for the blood parameters (hemoglobin, red and white blood cells, and cortisol levels) between healthy and on-treatment subjects (respectively 13.47±0.96 g/dL vs 5.37±0.38 g/dL, 4.58±0.41 1012/L vs 2.07±0.13 1012/L, and 6.15±1.03 109/L vs 0.86±0.41 109/L). Scores of the STM test were significantly lower for patients compared to healthy subjects. As indicated by the results of the questionnaire, breast cancer patients had a higher tendency to forget than healthy controls (X2=3.15; p<0.0001) and recovered subjects (X2=3.15; p<0.0001). Conclusion We found depleted levels of hemoglobin, red and white blood cells as a result of chemotherapy, and elevated levels of stress correlated with poor performances in the computerized STM test. A higher cortisol level might be an important precursor of STM deterioration. Monitoring cortisol would be beneficial for evaluating the quality of life of breast cancer patients on chemotherapy.

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