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Fulltext Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats

Suvarna R, Suryakanth VB, Bakthavatchalam P, Kalthur G, Nayak M D, Prabhu MM, et al.

J Ayurveda Integr Med, 2023 Oct 15;14(6):100804.
PMID: 37847964 DOI: 10.1016/j.jaim.2023.100804

BACKGROUND: The polyherbal formulation (PHF) liberin, is known to exert anti-hyperglycemic effects in type 2 diabetes mellitus. Hence, it is important to study the safety profile of PHF in the current study through acute and chronic toxicity evaluation.
OBJECTIVES: This research aims to assess the acute and sub-chronic toxicity of PHF in rats.
MATERIALS AND METHODS: PHF was administered once orally (1000 mg/kg body weight), and the rats (male and female) were monitored for toxicity signs for a 14-day period. For a 28-day chronic toxicity study, rats were daily administered with PHF dose of 500 mg/kg and 1000 mg/kg body weight. Rats were followed up for mortality, weight changes, and other morbidities. Further haematological, biochemical, and histopathological changes were assessed.
RESULTS: No death related to treatment or toxicity signs were recorded in the acute single-dose administration group. The results showed that the PHF was tolerated well up to a dose of 1000 mg/kg body weight. Even at the high dose of 1000 mg/kg body weight, sub-chronic tests did not show any significant difference between the dosed and normal groups. No significant changes were seen in the histopathological analysis of the liver, spleen, and kidney as well as haematological and biochemical parameters in acute, sub-chronic and satellite groups following the administration of PHF.
CONCLUSION: The results confirmed that there was no adverse effect of this PHF at the maximum dose of 1000 mg/kg body weight in Wistar rats. Further, no adverse delayed effects related to PHF were observed in the satellite group. Therefore, this PHF appears safe for therapeutic purposes in the Ayurvedic medicinal system.
Oral Health Status and Treatment Needs of Psychiatric Outpatients Aged 18-64 Years in District Civil Hospital, Raichur, Karnataka: A Cross-Sectional Study

Goud V, Kannaiyan K, Rao BV, Abidullah M, Dharani V, Nayak M

J Pharm Bioallied Sci, 2021 Jun;13(Suppl 1):S598-S601.
PMID: 34447161 DOI: 10.4103/jpbs.JPBS_776_20

Background: Psychiatric patients or mentally ill patients conform a substantial section of the community deserving special attention. This study aimed to assess the oral health status and treatment needs of psychiatric patients attending District Civil Hospital, Raichur, Karnataka.
Materials and Methods: The study group comprised 150 outpatients aged 18-64 years, attending the Department of Psychiatry, District Civil Hospital, Raichur. A specific questionnaire was drawn up and was used to record the demographic and medical data and oral hygiene practices. Type III clinical examination was carried out. The WHO Assessment Form 1997 was used to assess the oral health status of the study population.
Results: Of the 150 patients examined, 90 (60%) were male and 60 (40%) were female. The mean age of the patients was 33.79 ± 10.57 years. The majority (52%) were diagnosed with epilepsy and 18% had anxiety disorder. The prevalence of caries was 87.3%. Periodontal status, according to the Community Periodontal Index scores, was as follows: 54% of the patients had shallow pocket (4 mm-5 mm) and 32% of the patients had 6-mm or more deep pocket.
Conclusion: This study highlights a substantial need for prevention and treatment of oral health needs among psychiatric patients, and to increase awareness toward oral health.
Mechanistic insights into acyclovir-polyethylene glycol 20000 binary dispersions

Venkateskumar K, Parasuraman S, Gunasunderi R, Sureshkumar K, Nayak MM, Shah SA, et al.

Int J Pharm Investig, 2016 Oct-Dec;6(4):194-200.
PMID: 28123988 DOI: 10.4103/2230-973X.195925

The objective of this study is to provide a mechanistic insight into solubility enhancement and dissolution of acyclovir (ACY) by polyethylene glycol20000 (PEG20000).
Acyclovir-Polyethylene Glycol 6000 Binary Dispersions: Mechanistic Insights

Venkateskumar K, Parasuraman S, Gunasunderi R, Sureshkumar K, Nayak MM, Shah SAA, et al.

AAPS PharmSciTech, 2017 Aug;18(6):2085-2094.
PMID: 28004342 DOI: 10.1208/s12249-016-0686-9

The dissolution and subsequent oral bioavailability of acyclovir (ACY) is limited by its poor aqueous solubility. An attempt has been made in this work to provide mechanistic insights into the solubility enhancement and dissolution of ACY by using the water-soluble carrier polyethylene glycol 6000 (PEG6000). Solid dispersions with varying ratios of the drug (ACY) and carrier (PEG6000) were prepared and evaluated by phase solubility, in vitro release studies, kinetic analysis, in situ perfusion, and in vitro permeation studies. Solid state characterization was done by powder X-ray diffraction (XRD), differential scanning calorimetry (DSC), and Fourier transform infrared (FTIR) analysis, and surface morphology was assessed by polarizing microscopic image analysis, scanning electron microscopy, atomic force microscopy, and nuclear magnetic resonance analysis. Thermodynamic parameters indicated the solubilization effect of the carrier. The aqueous solubility and dissolution of ACY was found to be higher in all samples. The findings of XRD, DSC, FTIR and NMR analysis confirmed the formation of solid solution, crystallinity reduction, and the absence of interaction between the drug and carrier. SEM and AFM analysis reports ratified the particle size reduction and change in the surface morphology in samples. The permeation coefficient and amount of ACY diffused were higher in samples in comparison to pure ACY. Stability was found to be higher in dispersions. The results suggest that the study findings provided clear mechanical insights into the solubility and dissolution enhancement of ACY in PEG6000, and such findings could lay the platform for resolving the poor aqueous solubility issues in formulation development.
Fulltext Detection of Adherence of Enterococcus faecalis in Infected Dentin of Extracted Human Teeth Using Confocal Laser Scanning Microscope: An In vitro Study

Nair VS, Nayak M, Ramya MK, Sivadas G, Ganesh C, Devi SL, et al.

J Pharm Bioallied Sci, 2017 Nov;9(Suppl 1):S41-S44.
PMID: 29284934 DOI: 10.4103/jpbs.JPBS_92_17

AIM: The aim of this study is to detect in vitro adherence of Enterococcus faecalis to the infected dentinal tubules of human extracted teeth using confocal laser scanning microscope.
SUBJECTS AND METHODS: Roots from human premolar teeth (n = 40) were infected with E. faecalis strain the American Type Culture Collection 29212 in brain heart infusion for 21 days. After the experimental period, specimens were divided into two groups, Group A (n = 20), Group B (n = 20), and Group A specimens were stained with fluorescein diacetate dye for the detection of viability and adherence Group B were stained with acridine orange dye for detection of metabolic activity and adherence. Samples were washed, thoroughly sectioned and examined by confocal laser scanning microscopy. Computer-assisted determinants of fluorescence, bacterial viability, metabolic activity, and adherence were compared statistically.
RESULTS: E. faecalis was able to invade the dentinal tubules to a depth of 1-400 μm and adhere to 1-200 μm depth. Adherence (90%) was significantly higher in 1-100 μm using fluorescein diacetate and acridine orange dye.
CONCLUSION: Adherence of E. faecalis as evaluated by confocal laser scanning microscope was highest at the depth of 1-100 μm which may have an impact on the shaping and cleaning procedures on the root canal.
Observation of ϒ(2S)→γη_{b}(1S) Decay

Fulsom BG, Pedlar TK, Adachi I, Aihara H, Al Said S, Asner DM, et al.

Phys Rev Lett, 2018 Dec 07;121(23):232001.
PMID: 30576207 DOI: 10.1103/PhysRevLett.121.232001

We report the observation of ϒ(2S)→γη_{b}(1S) decay based on an analysis of the inclusive photon spectrum of 24.7 fb^{-1} of e^{+}e^{-} collisions at the ϒ(2S) center-of-mass energy collected with the Belle detector at the KEKB asymmetric-energy e^{+}e^{-} collider. We measure a branching fraction of B[ϒ(2S)→γη_{b}(1S)]=(6.1_{-0.7-0.6}^{+0.6+0.9})×10^{-4} and derive an η_{b}(1S) mass of 9394.8_{-3.1-2.7}^{+2.7+4.5} MeV/c^{2}, where the uncertainties are statistical and systematic, respectively. The significance of our measurement is greater than 7 standard deviations, constituting the first observation of this decay mode.
First Measurements of Absolute Branching Fractions of the Ξ_{c}^{0} Baryon at Belle

Li YB, Shen CP, Yuan CZ, Adachi I, Aihara H, Al Said S, et al.

Phys Rev Lett, 2019 Mar 01;122(8):082001.
PMID: 30932568 DOI: 10.1103/PhysRevLett.122.082001

We present the first measurements of absolute branching fractions of Ξ_{c}^{0} decays into Ξ^{-}π^{+}, ΛK^{-}π^{+}, and pK^{-}K^{-}π^{+} final states. The measurements are made using a dataset comprising (772±11)×10^{6} BB[over ¯] pairs collected at the ϒ(4S) resonance with the Belle detector at the KEKB e^{+}e^{-} collider. We first measure the absolute branching fraction for B^{-}→Λ[over ¯]_{c}^{-}Ξ_{c}^{0} using a missing-mass technique; the result is B(B^{-}→Λ[over ¯]_{c}^{-}Ξ_{c}^{0})=(9.51±2.10±0.88)×10^{-4}. We subsequently measure the product branching fractions B(B^{-}→Λ[over ¯]_{c}^{-}Ξ_{c}^{0})B(Ξ_{c}^{0}→Ξ^{-}π^{+}), B(B^{-}→Λ[over ¯]_{c}^{-}Ξ_{c}^{0})B(Ξ_{c}^{0}→ΛK^{-}π^{+}), and B(B^{-}→Λ[over ¯]_{c}^{-}Ξ_{c}^{0})B(Ξ_{c}^{0}→pK^{-}K^{-}π^{+}) with improved precision. Dividing these product branching fractions by the result for B^{-}→Λ[over ¯]_{c}^{-}Ξ_{c}^{0} yields the following branching fractions: B(Ξ_{c}^{0}→Ξ^{-}π^{+})=(1.80±0.50±0.14)%, B(Ξ_{c}^{0}→ΛK^{-}π^{+})=(1.17±0.37±0.09)%, and B(Ξ_{c}^{0}→pK^{-}K^{-}π^{+})=(0.58±0.23±0.05)%. For the above branching fractions, the first uncertainties are statistical and the second are systematic. Our result for B(Ξ_{c}^{0}→Ξ^{-}π^{+}) can be combined with Ξ_{c}^{0} branching fractions measured relative to Ξ_{c}^{0}→Ξ^{-}π^{+} to yield other absolute Ξ_{c}^{0} branching fractions.
Search for a Light CP-odd Higgs Boson and Low-Mass Dark Matter at the Belle Experiment

Seong IS, Vahsen SE, Adachi I, Aihara H, Al Said S, Asner DM, et al.

Phys Rev Lett, 2019 Jan 11;122(1):011801.
PMID: 31012694 DOI: 10.1103/PhysRevLett.122.011801

We report on the first Belle search for a light CP-odd Higgs boson, A^{0}, that decays into low mass dark matter, χ, in final states with a single photon and missing energy. We search for events produced via the dipion transition ϒ(2S)→ϒ(1S)π^{+}π^{-}, followed by the on-shell process ϒ(1S)→γA^{0} with A^{0}→χχ, or by the off-shell process ϒ(1S)→γχχ. Utilizing a data sample of 157.3×10^{6} ϒ(2S) decays, we find no evidence for a signal. We set limits on the branching fractions of such processes in the mass ranges M_{A^{0}}<8.97 GeV/c^{2} and M_{χ}<4.44 GeV/c^{2}. We then use the limits on the off-shell process to set competitive limits on WIMP-nucleon scattering in the WIMP mass range below 5 GeV/c^{2}.
Search for B^{-}→μ^{-}ν[over ¯]_{μ} Decays at the Belle Experiment

Sibidanov A, Varvell KE, Adachi I, Aihara H, Al Said S, Asner DM, et al.

Phys Rev Lett, 2018 Jul 20;121(3):031801.
PMID: 30085771 DOI: 10.1103/PhysRevLett.121.031801

We report the results of a search for the rare, purely leptonic decay B^{-}→μ^{-}ν[over ¯]_{μ} performed with a 711 fb^{-1} data sample that contains 772×10^{6} BB[over ¯] pairs, collected near the ϒ(4S) resonance with the Belle detector at the KEKB asymmetric-energy e^{+}e^{-} collider. The signal events are selected based on the presence of a high momentum muon and the topology of the rest of the event showing properties of a generic B-meson decay, as well as the missing energy and momentum being consistent with the hypothesis of a neutrino from the signal decay. We find a 2.4 standard deviation excess above background including systematic uncertainties, which corresponds to a branching fraction of B(B^{-}→μ^{-}ν[over ¯]_{μ})=(6.46±2.22±1.60)×10^{-7} or a frequentist 90% confidence level interval on the B^{-}→μ^{-}ν[over ¯]_{μ} branching fraction of [2.9,10.7]×10^{-7}.
Observation of ϒ(4S)→η^{'}ϒ(1S)

Guido E, Mussa R, Tamponi U, Aihara H, Al Said S, Asner DM, et al.

Phys Rev Lett, 2018 Aug 10;121(6):062001.
PMID: 30141661 DOI: 10.1103/PhysRevLett.121.062001

We report the first observation of the hadronic transition ϒ(4S)→η^{'}ϒ(1S), using 496 fb^{-1} data collected at the ϒ(4S) resonance with the Belle detector at the KEKB asymmetric-energy e^{+}e^{-} collider. We reconstruct the η^{'} meson through its decays to ρ^{0}γ and to π^{+}π^{-}η, with η→γγ. We measure B(ϒ(4S)→η^{'}ϒ(1S))=[3.43±0.88(stat)±0.21(syst)]×10^{-5}, with a significance of 5.7σ.
Observation of Transverse Λ/Λ[over ¯] Hyperon Polarization in e^{+}e^{-} Annihilation at Belle

Guan Y, Vossen A, Adachi I, Adamczyk K, Ahn JK, Aihara H, et al.

Phys Rev Lett, 2019 Feb 01;122(4):042001.
PMID: 30768311 DOI: 10.1103/PhysRevLett.122.042001

We report the first observation of the spontaneous polarization of Λ and Λ[over ¯] hyperons transverse to the production plane in e^{+}e^{-} annihilation, which is attributed to the effect arising from a polarizing fragmentation function. For inclusive Λ/Λ[over ¯] production, we also report results with subtracted feed-down contributions from Σ^{0} and charm. This measurement uses a dataset of 800.4 fb^{-1} collected by the Belle experiment at or near a center-of-mass energy of 10.58 GeV. We observe a significant polarization that rises with the fractional energy carried by the Λ/Λ[over ¯] hyperon.
First Evidence for cos2β>0 and Resolution of the Cabibbo-Kobayashi-Maskawa Quark-Mixing Unitarity Triangle Ambiguity

Adachi I, Adye T, Ahmed H, Ahn JK, Aihara H, Akar S, et al.

Phys Rev Lett, 2018 Dec 28;121(26):261801.
PMID: 30636113 DOI: 10.1103/PhysRevLett.121.261801

We present first evidence that the cosine of the CP-violating weak phase 2β is positive, and hence exclude trigonometric multifold solutions of the Cabibbo-Kobayashi-Maskawa (CKM) Unitarity Triangle using a time-dependent Dalitz plot analysis of B^{0}→D^{(*)}h^{0} with D→K_{S}^{0}π^{+}π^{-} decays, where h^{0}∈{π^{0},η,ω} denotes a light unflavored and neutral hadron. The measurement is performed combining the final data sets of the BABAR and Belle experiments collected at the ϒ(4S) resonance at the asymmetric-energy B factories PEP-II at SLAC and KEKB at KEK, respectively. The data samples contain (471±3)×10^{6}BB[over ¯] pairs recorded by the BABAR detector and (772±11)×10^{6}BB[over ¯] pairs recorded by the Belle detector. The results of the measurement are sin2β=0.80±0.14(stat)±0.06(syst)±0.03(model) and cos2β=0.91±0.22(stat)±0.09(syst)±0.07(model). The result for the direct measurement of the angle β of the CKM Unitarity Triangle is β=[22.5±4.4(stat)±1.2(syst)±0.6(model)]°. The measurement assumes no direct CP violation in B^{0}→D^{(*)}h^{0} decays. The quoted model uncertainties are due to the composition of the D^{0}→K_{S}^{0}π^{+}π^{-} decay amplitude model, which is newly established by performing a Dalitz plot amplitude analysis using a high-statistics e^{+}e^{-}→cc[over ¯] data sample. CP violation is observed in B^{0}→D^{(*)}h^{0} decays at the level of 5.1 standard deviations. The significance for cos2β>0 is 3.7 standard deviations. The trigonometric multifold solution π/2-β=(68.1±0.7)° is excluded at the level of 7.3 standard deviations. The measurement resolves an ambiguity in the determination of the apex of the CKM Unitarity Triangle.