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Background: "Hospitels" are hotels that have been specially converted to healthcare facilities. Their utilization emerged as a resource-optimization strategy during the peak of the COVID-19 pandemic in Thailand. This study evaluated the clinical characteristics, outcomes, and admission costs of asymptomatic and mild-to-moderate COVID-19 patients treated in these facilities., Methods: We conducted a retrospective analysis of adult COVID-19 patients who were admitted between July and October 2021 to two hospitels in Bangkok that were affiliated with Siriraj Hospital. Patient demographics, clinical data, vaccination status, treatment modalities, outcomes, and total costs were collected and analyzed via univariable and multivariable statistical methods., Results: Of the 1729 patients, 644 (37.2%) presented with abnormal baseline chest X-rays that could imply to moderate cases. These patients were older (49.2 vs. 42.2 years, P < 0.001), had greater body weights (68.1 vs. 64.7 kg, P < 0.001) and body mass indices (26.3 vs. 24.9 kg/m 2 , P < 0.001), and more frequently presented comorbidities. They demonstrated an increased risk for severe COVID-19 (P < 0.001), lower full vaccination rates (P < 0.001), and higher hospital referral rates (P < 0.001). Symptomatology was largely comparable between patients with normal and abnormal baseline chest X-rays, with significant differences noted only for cough and fatigue. While the admission costs of both groups were similar, the total costs for referred patients were sixfold greater than those for discharged patients (70 545 vs. 12 010 Thai Baht, P < 0.001)., Conclusions: Compared with patients with normal baseline chest X-rays, COVID-19 patients with abnormal chest X-rays admitted to hospitels presented higher comorbidity rates, greater severe disease risk, and increased hospital referral rates. Referrals from the hospitels back to Siriraj Hospital substantially escalated the total costs. Vigilant monitoring of patients with initial abnormal chest X-rays in hospitels is crucial for efficient management and resource allocation., Competing Interests: Declarations. Ethical approval and consent to participate: The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of the Faculty of Medicine Siriraj Hospital, Mahidol University (protocol code: 731/2564(IRB3); IRB certificate of approval number: Si 732/2021; approval date: March 14, 2023). Consent to participate was waived due to the retrospective nature of the study by the Institutional Review Board of the Faculty of Medicine Siriraj Hospital, Mahidol University. Clinical trial number: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

Intensive lifestyle interventions are effective in preventing T2DM, but evidence is lacking for high cardiometabolic individuals in hospital settings. We evaluated a hospital-based, diabetes prevention program integrating cognitive behavioral therapy (CBT) for individuals with prediabetes. This matched cohort assessed individuals with prediabetes receiving the prevention program, which were matched 1:1 with those receiving standard care. The year-long program included five in-person sessions and several online sessions covering prediabetes self-management, dietary and behavioral interventions. Kaplan-Meier and Cox regression models estimated the 60-month T2DM incidence rate. Of 192 patients, 190 joined the prevention program, while 190 out of 10,260 individuals were in the standard-care group. Both groups had similar baseline characteristics (mean age 58.9 ± 10.2 years, FPG 102.3 ± 8.2 mg/dL, HbA1c 5.9 ± 0.3%, BMI 26.2 kg/m 2 , metabolic syndrome 75%, and ASCVD 6.3%). After 12 months, the intervention group only showed significant decreases in FPG, HbA1c, and triglyceride levels and weight. At 60 months, the T2DM incidence rate was 1.7 (95% CI 0.9-2.8) in the intervention group and 3.5 (2.4-4.9) in the standard-care group. After adjusting for variables, the intervention group had a 0.46 times lower risk of developing diabetes. Therefore, healthcare providers should actively promote CBT-integrated, hospital-based diabetes prevention programs to halve diabetes progression., (© 2024. The Author(s).)

Introduction: Previous research has examined the association between coffee and tea consumption and non-alcoholic fatty liver disease (NAFLD). Preclinical studies have indicated the potential hepatoprotective properties of cocoa/chocolate. However, clinical research on the consumption of cocoa/chocolate and soft drinks and their relation to NAFLD, particularly among individuals with metabolic syndrome, is limited. This study primarily aimed to assess the association between beverage consumption and NAFLD in these patients., Methods: This cross-sectional study enrolled adult patients with metabolic syndrome visited the Medicine Outpatient Department at Siriraj Hospital, Thailand, from November 2011 to January 2013. The exclusion criteria were secondary causes of hepatic steatosis, such as excessive alcohol use, viral hepatitis, or drug-induced hepatitis. Participants completed a 23-item self-administered questionnaire covering their beverage consumption habits, including type, frequency, volume, duration, and additives in drinks, namely, coffee, tea, cocoa/chocolate, and soft drinks. To ensure accurate responses, these questionnaires were supplemented by face-to-face interviews. Ultrasonography was employed early in the methodology to diagnose NAFLD. Univariable analyses were used to compare the beverage consumption behaviors of participants with and without NAFLD. Multivariable logistic regression was used to adjust for potential confounders, including total beverage energy intake, age, anthropometric data, laboratory results, and comorbidities., Results: This study included 505 patients with metabolic syndrome. Of these, 341 (67.5%, 95%CI: 63.2-71.6%) were diagnosed with NAFLD. The consumption rates of coffee, cocoa/chocolate, and soft drinks were similar between the two groups. However, tea consumption was significantly more common in patients with NAFLD (68.3% vs. 51.8%, p  < 0.001). The groups had no significant differences in caffeine intake or total energy intake from beverages. Notably, daily intake of three or more cups of coffee was correlated with a reduced prevalence of NAFLD, with an adjusted odds ratio of 0.35 (95%CI: 0.14-0.89)., Conclusion: This study revealed that patients with metabolic syndrome, irrespective of NAFLD status, exhibited similar patterns of beverage consumption. While no definitive associations were identified between the intake of coffee, tea, cocoa/chocolate, or soft drinks and NAFLD, a notable exception was observed. A higher consumption of coffee (≥3 cups daily) was associated with a lower prevalence of NAFLD., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Kositamongkol, Ngaohirunpat, Samchusri, Chaisathaphol, Srivanichakorn, Washirasaksiri, Auesomwang, Sitasuwan, Tinmanee, Sayabovorn, Charatcharoenwitthaya and Phisalprapa.)

Scoring systems for metabolic dysfunction-associated steatotic liver disease (MASLD) in individuals with prediabetes have not been extensively explored. This study aimed to investigate the prevalence of MASLD and to develop predictive tools for its detection in high cardiometabolic people with prediabetes. A cross-sectional study was conducted using baseline data from the prediabetes cohort. All participants underwent transient elastography to assess liver stiffness. MASLD was defined using a controlled attenuation parameter value > 275 dB/m and/or a liver stiffness measurement ≥ 7.0 kPa. Cases with secondary causes of hepatic steatosis were excluded. Out of 400 participants, 375 were included. The observed prevalence of MASLD in individuals with prediabetes was 35.7%. The most effective predictive model included FPG ≥ 110 mg/dL; HbA1c ≥ 6.0%; sex-specific cutoffs for HDL; ALT ≥ 30 IU/L; and BMI levels. This model demonstrated good predictive performance with an AUC of 0.80 (95% CI 0.73-0.86). At a cutoff value of 4.5, the sensitivity was 70.7%, the specificity was 72.3%, the PPV was 58.8%, and the NPV was 81.5%. Our predictive model is practical, easy to use, and relies on common parameters. The scoring system should aid clinicians in determining when further investigations of MASLD are warranted among individuals with prediabetes, especially in settings with limited resources.

Few studies have identified the metabolic consequences of the post-acute phase of nonsevere COVID-19. This prospective study examined metabolic outcomes and associated factors in nonsevere, RT-PCR-confirmed COVID-19. The participants' metabolic parameters, the prevalence of long-term multiple metabolic abnormalities (≥ 2 components), and factors influencing the prevalence were assessed at 1, 3, and 6 months post-onset. Six hundred individuals (mean age 45.5 ± 14.5 years, 61.7% female, 38% high-risk individuals) with nonsevere COVID-19 attended at least one follow-up visit. The prevalence of worsening metabolic abnormalities was 26.0% for BMI, 43.2% for glucose, 40.5% for LDL-c, 19.1% for liver, and 14.8% for C-reactive protein. Except for lipids, metabolic-component abnormalities were more prevalent in high-risk hosts than in healthy individuals. The prevalence of multiple metabolic abnormalities at the 6-month follow-up was 41.3% and significantly higher in high-risk than healthy hosts (49.2% vs 36.5%; P = 0.007). Factors independently associated with a lower risk of these abnormalities were being female, having dyslipidemia, and receiving at least 3 doses of the COVID-19 vaccine. These findings suggest that multiple metabolic abnormalities are the long-term consequences of COVID-19. For both high-risk and healthy individuals with nonsevere COVID-19, healthcare providers should monitor metabolic profiles, encourage healthy behaviors, and ensure complete vaccination., (© 2023. Springer Nature Limited.)

The dynamics of humoral immune responses of patients after SARS-CoV-2 infection is unclear. This study prospectively observed changes in anti-receptor binding domain immunoglobulin G (anti-RBD IgG) and neutralizing antibodies against the Wuhan and Delta strains at 1, 3, and 6 months postinfection between October 2021 and May 2022. Demographic data, clinical characteristics, baseline parameters, and blood samples of participants were collected. Of 5059 SARS-CoV-2 infected adult patients, only 600 underwent assessment at least once between 3 and 6 months after symptom onset. Patients were categorized as immunocompetent ( n = 566), immunocompromised ( n = 14), or reinfected ( n = 20). A booster dose of a COVID-19 vaccine was strongly associated with maintained or increased COVID-19 antibody levels. The booster dose was also more strongly associated with antibody responses than the primary vaccination series. Among patients receiving a booster dose of a mRNA vaccine or a heterologous regimen, antibody levels remained steady or even increased for 3 to 6 months after symptom onset compared with inactivated or viral vector vaccines. There was a strong correlation between anti-RBD IgG and neutralizing antibodies against the Delta variant. This study is relevant to resource-limited countries for administering COVID-19 vaccines 3 to 6 months after infection.

This study aimed to evaluate the efficacy of early antiviral treatment in preventing clinical deterioration in asymptomatic or mildly symptomatic severe acute respiratory syndrome coronavirus 2 infected (COVID-19) patients in home isolation and to share our experiences with the ambulatory management of nonsevere COVID-19 patients. This retrospective study included mild COVID-19 adult patients confirmed by real-time reverse transcription-polymerase chain reaction. They received care via an ambulatory management strategy between July 2021 and November 2021. Demographic data, clinical progression, and outcomes were collected. Both descriptive and inferential statistics were performed to illustrate the cohort's characteristic and outcomes of the study. Univariable and multivariable logistic regression models were employed to investigate the associations between clinical factors and disease progression. A total of 1940 patients in the Siriraj home isolation system met the inclusion criteria. Their mean age was 42.1 ± 14.9 years, with 14.2% older than 60 years, 54.3% female, and 7.1% with a body weight ≥ 90 kg. Only 115 patients (5.9%) had deterioration of clinical symptoms. Two-thirds of these could be managed at home by dexamethasone treatment under physician supervision; however, 38 of the 115 patients (2.0% of the study cohort) needed hospitalization. Early favipiravir outpatient treatment (≤ 5 days from onset of symptoms) in nonsevere COVID-19 patients was significantly associated with a lower rate of symptom deterioration than late favipiravir treatment (50 [4.6%] vs 65 [7.5%] patients, respectively; P = .008; odds ratio 1.669; 95% confidence interval, 1.141-2.441). The unfavorable prognostic factors for symptom deterioration were advanced age, body weight ≥ 90 kg, unvaccinated status, higher reverse transcription-polymerase chain reaction cycle threshold, and late favipiravir treatment. The early delivery of essential treatment, including antiviral and supervisory dexamethasone, to ambulatory nonsevere COVID-19 patients yielded favorable outcomes during the COVID-19 pandemic in Thailand., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: The incidences of diabetes and diabetic retinopathy (DR) in Thai high-risk individuals with prediabetes have not been identified. This study compared diabetes and DR incidences among people at risk with different glycemic levels, using fasting plasma glucose (FPG) and hemoglobin A1C (HbA1c). Materials and methods: A historical cohort study estimating risk of type 2 diabetes and DR was conducted among outpatients, using FPG and HbA1c measurements at recruitment and monitored for ≥5 years. High-risk participants (defined as having metabolic syndrome or atherosclerotic cardiovascular disease) were categorized by glycemic level into 4 groups: 1) impaired fasting glucose (IFG)-/HbA1c- (FPG <110 mg/dl; HbA1c < 6.0%); 2) IFG+/HbA1c- (FPG 110-125 mg/dl; HbA1c < 6.0%); 3) IFG-/HbA1c+ (FPG <110 mg/dl; HbA1c 6.0%-6.4%); and 4) IFG+/HbA1c+ (FPG 110-125 mg/dl; HbA1c 6.0%-6.4%). The incidences of type 2 diabetes mellitus (T2DM) and DR were obtained and estimated using Kaplan-Meier analysis. Cox regression models explored hazard ratios (HRs). Results: We recruited 8,977 people at risk (metabolic syndrome, 89.9%; atherosclerotic cardiovascular disease, 16.9%). The baseline cohort consisted of 1) IFG-/HbA1c- ( n = 4,221; 47.0%); 2) IFG+/HbA1c- ( n = 1,274; 14.2%); 3) IFG-/HbA1c+ ( n = 2,151; 24.0%); and 4) IFG+/HbA1c+ ( n = 1,331; 14.8%). Their 5-year T2DM incidences were 16.0%, 26.4%, 30.8%, and 48.5% ( p < 0.001). The median DR follow-up was 7.8 years (interquartile range, 7.0-8.4 years). The DR incidences were 0.50, 0.63, 1.44, and 2.68/1,000 person-years ( p < 0.001) for IFG-/HbA1c-, IFG+/HbA1c-, IFG-/HbA1c+, and IFG+/HbA1c+, respectively. Compared with IFG-/HbA1c-, the multivariable-adjusted HRs (95% CI) for incident diabetes were 1.94 (1.34-2.80), 2.45 (1.83-3.29), and 4.56 (3.39-6.15) for IFG+/HbA1c-, IFG-/HbA1c+, and IFG+/HbA1c+, respectively. As for incident DR, the corresponding HRs were 0.67 (0.08-5.76), 4.74 (1.69-13.31), and 5.46 (1.82-16.39), respectively. Conclusion: The 5-year incidence of T2DM in Thai high-risk participants with prediabetes was very high. The incidences of diabetes and DR significantly increased with higher degrees of dysglycemia. High-risk people with FPG 110-125 mg/dl and HbA1c 6.0%-6.4% were more likely to develop T2DM and DR. Such individuals should receive priority lifestyle and pharmacological management., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Washirasaksiri, Srivanichakorn, Borrisut, Sitasuwan, Tinmanee, Kositamongkol, Ariyakunaphan, Auesomwang, Sayabovorn, Chaisathaphol and Phisalprapa.)

Metabolic syndrome (MetS) patients are at higher risk for nonalcoholic fatty liver disease (NAFLD), atherosclerotic cardiovascular diseases (ASCVD), and death. Given a lack of longitudinal data on patients with MetS in Southeast Asia, this study investigated the incidence of NAFLD and ASCVD and the all-cause mortality rate during a 10-year follow-up of Thai patients with MetS. Retrospective data were collected on 496 MetS patients with ultrasonography or transient elastography results. The patients had been followed up continuously by a university hospital between October 2011 and November 2021, and their mean age was 61.0 ± 10.9 years. Patients with secondary causes of hepatic steatosis were excluded. Cox proportional hazards regression models with time-varying covariates were adopted. During the 10-year follow-up, 17 patients (11.2%) developed NAFLD, and 27 (6.4%) developed ASCVD. The NAFLD and ASCVD incidence rates were 21.7 and 10.9 events per 1000 person years, respectively. The mortality rate was 14.2 deaths per 1000 person years. The prevalence of hypertension, dyslipidemia, ASCVD, NAFLD, advanced fibrosis, and cirrhosis at baseline was significantly higher in the nonsurvival group. The NAFLD incidence and mortality rate of patients with MetS were lower than those in previous studies. Intensive, holistic, and continuous care should be considered for better outcomes.

This study aimed to assess the clinical characteristics of patients who registered at the Siriraj Favipiravir Clinic and to share our experiences in this comparatively unique clinical setting. This retrospective study included patients who registered at the Siriraj Favipiravir Clinic during August 11, 2021 to September 14, 2021. Included adult patients were those with severe acute respiratory syndrome coronavirus 2 (coronavirus disease 2019 [COVID-19]) infection confirmed by antigen test kit (ATK) or real-time reverse transcription-polymerase chain reaction, no favipiravir contraindication, no prior COVID-19 treatment, and not receiving care from another medical facility. Demographic data and outcomes were collected and analyzed. Of the 1168 patients (mean age: 44.8 ± 16.4 years, 55.7% female) who registered at the clinic, 117 (10%) did not meet the treatment criteria, and 141 (12%) patients did not pick up their medication. One-third of patients had at least 1 symptom that indicated severe disease. Higher proportion of unvaccinated status (56.7% vs 47.5%, P = .005), higher proportion of persons with risk factors for disease progression (37.7% vs 31.3%, P = .028), and longer duration between the date of clinic registration and the date of positive diagnostic test (3 vs 2 days, P = .004) were significantly more commonly observed in the severe disease group compared to the nonsevere disease group. The duration between symptom onset and the date of clinic registration was significantly longer in the real-time reverse transcription-polymerase chain reaction group than in the ATK group (6 vs 4 days, P < .001). Most patients (90.0%) had completed favipiravir treatment regimen. The improvement and mortality rates were 86.7% and 1.2%, respectively. COVID-19 severity is associated with vaccination status, baseline risk factors, and timing between disease detection and treatment. The use of ATK influences patients to seek treatment significantly earlier in ambulatory setting. Our early diagnosis and antiviral treatment strategy yielded favorable results in an outpatient setting during a COVID-19 outbreak in Thailand., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: In December 2021, Omicron replaced Delta as the dominant coronavirus disease 2019 (COVID-19) variant in Thailand. Both variants embody diverse epidemiological trends and immunogenicity. We investigated whether Delta and Omicron patients’ biological and clinical characteristics and immunogenicity differed post-COVID-19 infection. Methods: This retrospective cohort study investigated the clinical outcomes and laboratory data of 5181 patients with mild-to-moderate COVID-19 (Delta, 2704; Omicron, 2477) under home isolation. We evaluated anti-receptor-binding domain immunoglobulin G (anti-RBD IgG) and surrogate viral neutralizing (sVNT) activity in 495 individuals post-COVID-19 infection during the Delta pandemic. Results: Approximately 84% of all patients received favipiravir. The median cycle threshold (Ct) values were lower for Omicron patients than Delta patients (19 vs. 21; p < 0.001), regardless of vaccination status. Upper respiratory tract symptoms were more frequent with Omicron patients than Delta patients. There were no significant associations between Ct and Omicron symptoms (95% confidence interval 0.98−1.02). A two-dose vaccine regimen reduced hospital readmission by 10% to 30% and death by under 1%. Anti-RBD IgG and sVNT against Delta were higher among older individuals post-COVID-19 infection. Older individuals expressed anti-RBD IgG and sVNT for a more extended period after two-dose vaccination than other age groups. Conclusions: After a full vaccination course, breakthrough mild-to-moderate Delta and Omicron infections have limited immunogenicity. Prior infections exert reduced protection against later reinfection or infection from novel variants. However, this protection may be sufficient to prevent hospitalization and death, particularly in countries where vaccine supplies are limited.

This study investigated differences in the clinical data and prevalence of lean and non-lean patients with non-alcoholic fatty liver disease (NAFLD) and metabolic syndrome (MetS). Data on patients with MetS who had results of ultrasonography or transient elastography were collected from a Thai university hospital database. Patients with exclusion criteria for NAFLD diagnosis were excluded. Patients' clinical characteristic and the performances of three non-invasive scoring systems (fatty liver index [FLI], fibrosis-4 [FIB-4] index, and NAFLD fibrosis score [NFS]) were evaluated. The 743 subjects were classified into two groups: lean MetS (131 patients) and non-lean MetS (612 patients). The NAFLD prevalence in the non-lean group (62.6%) was higher than that in the lean group (31.3%). The age-adjusted odds ratio was 3.43. Advanced fibrosis was detected in 7.6% of lean patients and 10.8% of non-lean patients. FLI was not sensitive enough to detect NAFLD in the lean group at a high cutoff, but it performed acceptably at a low cutoff. FIB-4 performed better than NFS in determining advanced fibrosis. NAFLD was more common in non-lean than lean patients. Lean patients with MetS had a relatively higher risk of NAFLD than the general population. FLI and FIB-4 index performed acceptably in both groups.

Abstract: Care maps (CMs), which are innovative, comprehensive, educational, and simple medical tools, were developed for 6 common diseases, including heart failure, stroke, hyperglycemia, urinary tract infection, dengue infection, and upper gastrointestinal bleeding, were implemented in a short-stay ambulatory ward. This study aimed to investigate the effectiveness of and level of clinician satisfaction with CMs in an ambulatory care setting.A retrospective chart review study comparing the quality of care between before and after CM implementation was conducted. The medical records of patients who were admitted to a short-stay ambulatory ward in a tertiary referral center were reviewed. Demographic data, severity of disease, quality of care, length of stay (LOS), admission cost, and CM user satisfaction were collected and recorded.The medical records of 1116 patients were evaluated. Of those, 589 and 527 patients were from before (non-CM group) and after CM (CM group) implementation, respectively. There were no significant differences between groups for age, gender, or disease-specific severity the median (interquartile range) total and essential quality scores were significantly higher in the CM group than in the non-CM group [total quality score 85.3 (75.0-92.9) vs 61.1 (50.0-75.0); P < .001, and essential quality scores 90.0 (75.0-100.0) vs 60.0 (40.6-80.0); P < .0001, respectively]. All aspects of quality of care were significantly improved between before and after CM implementation. Overall median LOS was significantly decreased from 3.8 (2.5-5.7) to 3.0 (2.0-4.9) days, but there was no significant decrease for admission cost. However, CMs were able to significantly reduce both LOS and admission cost in the infectious disease-related subgroup. Most CM users reported satisfaction with CMs.CMs were shown to be an effective tool for improving the quality of care in patients with ambulatory infectious diseases. In that patient subgroup, LOS and admission cost were both significantly reduced compared to pre-CM implementation., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)

Purpose: The purpose of the research described herein was to develop a kinetic model for quantifying the effects of conditional and compositional variations on non-covalent polymorphic and covalent chemical transformations of gabapentin., Methods: Kinetic models that describe the relationship between polymorphs and degradation product in a series of sequential or parallel steps were devised based on analysis of the resultant concentration time profiles. Model parameters were estimated using non-linear regression and Bayesian methods and evaluated in terms of their quantitative relationship to compositional and conditional variations., Results: The model was constructed in which co-milling gabapentin with excipients determined three physically-initial concentrations (II 0 *, II 0 and III 0 ) and one chemically-initial concentration (lactam 0 ). For chemical transitions, no humidity effect was present but the catalytic effects of excipients on the conversion of II and III➔lactam were observed. For physical transition, excipient primarily influenced the physical state transition of III➔II through its ability to interact with humidity., Conclusions: This model was shown to be robust to quantitatively account for the effects of temperature, humidity and excipient on rate constants associated with kinetics for each physical and chemical transition.

Gabapentin was used as a model pharmaceutical compound with susceptibility to polymorphic transformation as a function of environmental and mechanical stress. The utility of 13 C CP/MAS NMR and XRPD as stability-indicating methods to quantify polymorphic transformation kinetics was investigated. Polymorphic Form II and III were distinguishable based on their chemical shift and distinct diffraction peak differences. Reproducible and accurate quantification of polymorphic composition in the presence of selected excipients was demonstrated using both signals from 13 C CP/MAS NMR spectra and XRPD patterns. The effect of excipients on polymorphic transformations (Form II→III) was determined by measuring the transformation after co-milling. Both 13 C CP/MAS NMR and XRPD were capable of measuring polymorphic composition in co-milled excipient mixtures without excipient peak interference. The amounts of Form III present in co-milled mixtures containing colloidal silicon dioxide, starch, hydroxy propyl cellulose and dibasic calcium phosphate were 8.7, 21, 33, and 39mol%, respectively. A quenching procedure for obtaining 13 C CP/MAS NMR spectra and environmentally-controlled XRPD were devised to determine polymorphic transformation kinetics of co-milled excipient mixtures during storage., (Copyright © 2017 Elsevier B.V. All rights reserved.)

We report a case of insulin autoimmune syndrome associated with several autoantibodies, presenting with recurrent hypoglycemia, predominantly in the postprandial period, which improved by dietary management and spontaneously resolved within two months. Differentiation from other causes of hyperinsulinemic hypoglycemia, such as insulinoma, is important to avoid unnecessary invasive procedures or surgical interventions. The 75-gram oral glucose tolerance test (OGTT) and mixed meal test showed a typical pattern, which may be useful indirect evidence of insulin autoimmune syndrome.

Gabapentin degrades directly to gabapentin-lactam (gaba-L) in the solid state. The objective of this study was to formulate a drug degradation model that accounted for the environmental storage conditions and mechanical stress (prior to storage) on lactamization kinetics. The effects of mechanical stress on drug degradation kinetics were determined by milling gabapentin in a FRITSCH Planetary Micro Mill for 0 and 60 min. The resultant gabapentin powder was stored at 40 °C-60 °C and 5%-30% relative humidity. The rate of gaba-L formation was measured by high-performance liquid chromatography. An irreversible two-step autocatalytic reaction scheme was fit using nonlinear regression methods. The resultant kinetic model was used to predict the time-dependent concentration of degradant of gabapentin tablets prepared under various exemplary manufacturing conditions, thereby demonstrating the ability of the model to link manufacturing variation and chemical stability in solid-state gabapentin formulations., (Copyright © 2012 Wiley Periodicals, Inc.)