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1.
Indian J Crit Care Med ; 27(9): 635-641, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37719359

RESUMO

Background: Critically ill patients are frequently transported to various locations within the hospital for diagnostic and therapeutic purposes, which increases the risk of adverse events (AEs). This multicenter prospective observational study was undertaken to determine the incidence of AEs related to intrahospital transport, their severity, and their effects on patient outcomes. Patients and methods: We included consecutive unstable critically ill patients requiring intrahospital transport, across 15 Indian tertiary care centers over 5 months (October 11, 2022-February 20, 2023). Apart from the demographics and severity of illness, data related to transport itself, such as indications and destination, incidence of AEs, their category and treatment required, and patient outcomes, were recorded in a standard form. Results: Eight hundred and ninety-three patients were transported on 1065 occasions out of the intensive care unit (ICU). The mean (SD) acute physiology and chronic health evaluation II score of the patients was 15.38 (±7.35). One hundred and two AEs occurred, wherein cardiovascular instability was the most common occurrence (31, 30.4%). Two patients had cardiac arrest immediately after transport. Acute physiology and chronic health evaluation II [odds ratio (OR): 1.02, 95% confidence interval (CI) - 1.00-1.05, p = 0.04], emergent transport (OR: 5.11, 95% CI - 3.32-7.88, p = 0.00), and team composition (OR: 5.34, 95% CI - 1.63-17.5, p = 0.00) during transport were found to be independent predictors of AEs. Conclusion: We found a high incidence of AEs during intrahospital transport of critically ill patients. These events were more common during emergent transports and when the patients were transported by doctors. Transport by itself was not related to ICU mortality. We feel that stabilization of the patients before transport and adherence to a standardized protocol may help in minimizing the AEs, thereby enhancing patient safety. How to cite this article: Zirpe KG, Tiwari AM, Kulkarni AP, Govil D, Dixit SB, Munjal M, et al. Adverse Events during Intrahospital Transport of Critically Ill Patients: A Multicenter, Prospective, Observational Study (I-TOUCH Study). Indian J Crit Care Med 2023;27(9):635-641.

2.
Med Mycol ; 60(9)2022 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-36029277

RESUMO

We describe presenting clinical and imaging manifestations of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-associated Rhino-oculo-cerebral mucormycosis (ROCM) in a hospital setting during the second wave of SARS-CoV-2 pandemic in India. Data on the presenting manifestations were collected from 1 March to 31 May 2021. Associations between clinical and imaging findings were explored, specifically: (1) the presence or absence of orbital pain and infiltration of a superior orbital fissure on imaging; (2) the presence of unilateral facial nerve palsy and pterygopalatine fossa infiltration and geniculate ganglion signal on contrast magnetic resonance imaging, and (3) vision loss and optic nerve findings on imaging. Orbital pain was reported by 6/36 subjects. A fixed, frozen eye with proptosis and congestion was documented in 26 (72%), complete vision loss in 23 (64%), and a unilateral lower motor neuron facial nerve palsy in 18 (50%). No association was found between the presence of orbital pain and superior orbital fissure infiltration on imaging. The ipsilateral geniculate ganglion was found to enhance more profoundly in 7/11 subjects with facial palsy and available magnetic resonance (MR) imaging, and the ipsilateral pterygopalatine fossa was found infiltrated in 14. Among 23 subjects with complete loss of vision, 9 (39%) demonstrated long-segment bright signal in the posterior optic nerve on diffusion MR images. We conclude that orbital pain might be absent in SARS-CoV-2-associated ROCM. Facial nerve palsy is more common than previously appreciated and ischemic lesions of the posterior portion of the optic nerve underlie complete vision loss.


Unique clinical and radiological manifestations identified in the outbreak of Rhino-oculo-cerebral mucormycosis (ROCM) during the second epidemic wave of coronavirus disease 2019 (COVID-19) infection included the common occurrence of facial paralysis, frequent absence of ocular pain, and long segments of optic nerve damage.


Assuntos
COVID-19 , Mucormicose , Animais , COVID-19/complicações , COVID-19/veterinária , Humanos , Mucormicose/diagnóstico por imagem , Mucormicose/veterinária , Dor/veterinária , Paralisia/veterinária , SARS-CoV-2
3.
Indian J Crit Care Med ; 25(11): 1280-1285, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34866826

RESUMO

INTRODUCTION: There is strong evidence for the use of corticosteroid in the management of severe coronavirus disease-2019 (COVID-19). However, there is still uncertainty about the timing of corticosteroids. We undertook a modified Delphi study to develop expert consensus statements on the early identification of a subset of patients from non-severe COVID-19 who may benefit from using corticosteroids. METHODS: A modified Delphi was conducted with two anonymous surveys between April 30, 2021, and May 3, 2021. An expert panel of 35 experts was selected and invited to participate through e-mail. The consensus was defined as >70% votes in multiple-choice questions (MCQ) on Likert-scale type statements, while strong consensus as >90% votes in MCQ or >50% votes for "very important" on Likert-scale questions in the final round. RESULTS: Twenty experts completed two rounds of the survey. There was strong consensus for the increased work of breathing (95%), a positive six-minute walk test (90%), thorax computed tomography severity score of >14/25 (85%), new-onset organ dysfunction (using clinical or biochemical criteria) (80%), and C-reactive protein >5 times the upper limit of normal (70%) as the criteria for patients' selection. The experts recommended using oral or intravenous (IV) low-dose corticosteroids (the equivalent of 6 mg/day dexamethasone) for 5-10 days and monitoring of oxygen saturation, body temperature, clinical scoring system, blood sugar, and inflammatory markers for any "red-flag" signs. CONCLUSION: The experts recommended against indiscriminate use of corticosteroids in mild to moderate COVID-19 without the signs of clinical worsening. Oral or IV low-dose corticosteroids (the equivalent of 6 mg/day dexamethasone) for 5-10 days are recommended for patients with features of disease progression based on clinical, biochemical, or radiological criteria after 5 days from symptom onset under close monitoring. HOW TO CITE THIS ARTICLE: How to cite this article: Nasa P, Chaudhry D, Govil D, Daga MK, Jain R, Chhallani AA, et al. Expert Consensus Statements on the Use of Corticosteroids in Non-severe COVID-19. Indian J Crit Care Med 2021;25(11):1280-1285.

4.
Indian J Crit Care Med ; 24(7): 565-569, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32963441

RESUMO

COVID-19 outbreak has caused a pandemonium in modern world. As the virus has spread its tentacles across nations, territories, and continents, the civilized society has been compelled to face an unprecedented situation, never experienced before during peacetime. We are being introduced to an ever-growing new terminologies: "social distancing," "lockdown," "stay safe," "key workers," "self-quarantine," "work-from-home," and so on. Many countries across the globe have closed their borders, airlines have been grounded, movement of public transports has come to a grinding halt, and personal vehicular movements have been restricted or barred. In the past couple of months, we have witnessed mayhem in an unprecedented scale: social, economic, food security, education, business, travel, and freedom of movements are all casualties of this pandemic. Our experience about this virus and its epidemiology is limited, and mostly the treatment for symptomatic patients is supportive. However, it has been observed that COVID-19 not only attacks the respiratory system; rather it may involve other systems also from the beginning of infection or subsequent to respiratory infection. In this article, we attempt to describe the systemic involvement of COVID-19 based on the currently available experiences. This description is up to date as of now, but as more experiences are pouring from different corners of the world, almost every day, newer knowledge and information will crop up by the time this article is published. HOW TO CITE THIS ARTICLE: Munjal M, Das S, Chatterjee N, Setra AE, Govil D. Systemic Involvement of Novel Coronavirus (COVID-19): A Review of Literature. Indian J Crit Care Med 2020;24(7):565-569.

5.
Indian J Crit Care Med ; 24(9): 763-770, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33132557

RESUMO

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) and has been declared as a pandemic. COVID-19 patients may require transport for diagnostic or therapeutic purposes intra- or interhospital or transport from an outside hospital to a healthcare facility. Transport of critically ill or infectious patients is always challenging and involves the integration of various tasks and manpower. The adverse events have been attributed to various factors such as a multidisciplinary team and lack of appropriate communication among team members, absence of equipment, or failure during transport, apart from physiological alteration inherent to the disease of the patient. The transport of COVID-19 patients carries an additional risk of not only the disease itself but also due to the risk of its transmission to the transport team. The human-to-human transmission of the virus can occur via respiratory droplets. So, the person involved in the transport of such patients shall be at risk and warrants appropriate steps for their safety. Appropriate planning by a well-trained transport team is an essence for the safe transport of the suspected or confirmed COVID-19 patients. The Transport Medicine Society guidelines present consensus guidelines for the safe transport of COVID-19 patients. DISCLAIMER: These consensus guidelines are applicable for the safe transport of suspected or confirmed COVID-19 adult patients. These recommendations should be used in conjunction with medical management guidelines and advisories related to COVID-19. These recommendations should be adapted to the local policies prevalent at the workplace and also per agreement among the hospitals for transport (agreement between referring and receiving facilities). With the emergence of new scientific evidence, these guidelines may require modification. HOW TO CITE THIS ARTICLE: Munjal M, Ahmed SM, Garg R, Das S, Chatterjee N, Mittal K, et al. The Transport Medicine Society Consensus Guidelines for the Transport of Suspected or Confirmed COVID-19 Patients. Indian J Crit Care Med 2020;24(9):763-770.

6.
Am J Otolaryngol ; 35(3): 435-8, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24636915

RESUMO

Primary lymphomas of the oral cavity are uncommon and of the tongue even rarer. It is more common in the masticatory mucosa than the lingual and buccal mucosa. We describe a 63 year old male who presented with dysphagia & change in voice. Computed tomography revealed a 4.8 × 3.7 cm mass localized to the base of tongue. He underwent biopsy and IHC studies & was diagnosed as having diffuse large B cell lymphoma. The patient was successfully treated with wide excision of the lesion and is undergoing chemotherapy now. Although oral lymphoma of tongue is very uncommon, it should always be considered in differential diagnosis of various benign and malignant lesions in this region. A proper clinical evaluation and histopathologic as well as immunohistochemical evaluation of biopsy specimen are required to establish the diagnosis and for further management. This is one of the few cases of non-Hodgkin's lymphoma of the base of tongue being reported from India.


Assuntos
Linfoma Difuso de Grandes Células B/patologia , Neoplasias da Língua/patologia , Humanos , Imuno-Histoquímica , Linfoma Difuso de Grandes Células B/terapia , Masculino , Pessoa de Meia-Idade , Neoplasias da Língua/terapia
7.
Indian J Otolaryngol Head Neck Surg ; 75(4): 3883-3885, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37974703

RESUMO

Persistent tracheo-cutaneous fistulae necessitate a closure with pedicled or free flaps. The modality adopted is to reconstitute the anterior tracheal wall without compromising the tracheal lumen. We have developed the lateral U advancement Burrow's flap over the strap muscles and tracheal lateral fibrous flaps, to repair a large trachea-cutaneous fistula.

8.
Cureus ; 14(12): e32515, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36654572

RESUMO

Background Severe postoperative pain and immobility increase the length of hospital stay and immobility-related life-threatening complications after total hip replacement (THR). Pericapsular nerve group (PENG) block is a recent addition to pain management of neck of femur (NoF) fracture, the use of which has been incorporated into THR as alternative analgesia or as an adjunct with other regional analgesia techniques. The present study primarily aims to assess postoperative mobility. Secondary outcomes measured were the length of hospital stay, pain score, opioid consumption, and side effects. Methods This is a retrospective study of 50 patients who underwent primary THR. Twenty-eight patients received PENG block after spinal anesthesia (PENG Group), seven patients had general anesthesia (GA) with patient-controlled analgesia (PCA) postoperatively (PCA Group), and the remaining 15 received spinal anesthesia with fascia iliaca block (FIB Group). Mobilization was attempted in all patients (ability to stand and walk a few steps with a walker) 10 hours after the end of surgery. Data was collected for average postoperative pain score, time of mobilization, total opioid consumption (till discharge from the hospital), opioid-related side effects, and time of discharge. Results Mobilization was attempted in all patients 10 hours after the end of the surgery, irrespective of their anesthetic technique. In the PENG Group, 26 patients (n=28) could be mobilized after the first 10 hours without opioids. The total morphine requirement until discharge was significantly less in the PENG Group of patients compared to the FIB and GA+PCA patients. The average time of discharge (hours) from the hospital (22.1+/-4.9) was also significantly lower in the PENG Group compared to all other groups (31.7 +/- 3.4, p=<0.01). The average postoperative pain score was significantly low in the PENG Group within the first 48 hours. Conclusion The PENG block helps in early mobilization and enhanced recovery after THR.

9.
Indian J Otolaryngol Head Neck Surg ; 74(Suppl 3): 4837-4840, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36742633

RESUMO

Apnoea graph (AG) system is a new technology designed for evaluation of Sleep Disordered Breathing and more importantly the site of obstruction in Obstructive Sleep Apnoea (OSA). Apnoea Graph being a new modality of assessment needs to be evaluated with the time tested gold standard PolySomnoGraphy (PSG) along with its unique capability of establishing the level of obstruction. A prospective study of 30 patients of snoring and/or suspected for OSA was conducted in Sir Ganga Ram Hospital, New Delhi with recordings of both overnight sleep study and apnoea graph performed separately for each patient. The respiratory parameters of AG were compared with PSG. The percentage (%) of levels of obstruction identified by apnoea graph was calculated. We found that apnoea graph system was capable of diagnosing OSA and could also grade its severity. On comparing this new tool with PSG, we could deduce that there was comparability between the two tests with respect to pulse oximetry parameters with limitations with respect to Apnoea/ Hypopnoea Index (AHI) levels. The advantages and limitations of apnoea graph are highlighted. We conclude that Apnoea Graph is an innovative tool having the ability to diagnose the site of airway resistance and proves to be a valuable guide to the surgeon to select the most appropriate treatment in OSA.

10.
Laryngoscope ; 132(12): 2344-2349, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35289948

RESUMO

OBJECTIVE: To analyze the long-term symptomatic results of laser-assisted sialolithotripsy (LAS) in cases of obstructive sialolithiasis and correlate with objective criteria using diagnostic sialendoscopy (DS) as a method of examination. METHODS: This is a retrospective study comprising 50 consecutive patients who underwent holmium-YAG LAS and completed follow-up of at least 6 months. Symptom scoring and endoscopic scoring were done at 6 weeks and 6 months intervals for further study purposes. RESULTS: At the end of 6 weeks post-LAS, 70% patients were asymptomatic (A-sym) and only 30% had residual symptoms (Sym). However, obstructed duct (OB-duct) was observed on endoscopic scoring in 88% due to stenosis, residual stones, or both stenosis and residual stones. The obstructed ducts were treated in outpatient clinic and followed up over time, leading to 98% of patients being in A-sym group at the end of study period of 6 months. At the end of study, 82% of patients had clear duct (CL-duct). CONCLUSION: Holmium LAS is a viable option for the management of intermediate-sized stones. LAS if used judiciously, and in properly selected cases, has high rate of stone fragmentation and symptom resolution. A vigilant postoperative protocol taking into account residual mealtime symptoms and altered salivary characteristics combined with early DS can help identify and treat patients with residual stone fragments and ductal stenosis. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:2344-2349, 2022.


Assuntos
Lasers de Estado Sólido , Cálculos das Glândulas Salivares , Humanos , Estudos Retrospectivos , Constrição Patológica/cirurgia , Hólmio , Resultado do Tratamento , Cálculos das Glândulas Salivares/cirurgia , Endoscopia/métodos , Lasers de Estado Sólido/uso terapêutico
11.
Indian J Otolaryngol Head Neck Surg ; 74(Suppl 2): 2445-2457, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36452817

RESUMO

Neoplasia of the head and the neck necessitates intervention, surgical or otherwise, as the site and stage of the pathology may dictate. The various therapeutic modalities employed and prognosis has been reviewed.

12.
Indian J Otolaryngol Head Neck Surg ; 73(4): 447-454, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34692457

RESUMO

Resection and anastomosis is an effective option for the management of complex tracheal stenosis, however, it's not without the complications. This study aims at evaluating various factors predicting anastomotic complications after trachea resection and anastomosis. This is a retrospective analysis of database from a dedicated thoracic surgical unit in New Delhi, India over 7 years. An analysis of demographic details, perioperative variables including complications were carried out. Analysis of various factors predicting anastomotic complications was performed. Out of 65 patients in the study, 49 (75.3%) were males and 16 (24.7%) were females. Median age of the patients was 31 years. Stenosis was cervical in 80%, cervico-thoracic in 15.4% and thoracic in 4.6% of patients. Median length of stenosis was 2.9 cm (1-4.2). 53 (81.6%) patients had some kind of preoperative intervention, where as rest 12 (18.4%) patients had no intervention at all. Out of 65 patients, 26 (40%) had crico-tracheal anastomosis while 39 (60%) had tracheo-tracheal anastomosis. Median length of resected tracheal segment was 3.3 cm (1-5). Overall complication rate (anastomotic + non-anastomotic) was 18.4% in which anastomosis related were in 4 (6.1%) patients. Resection of tracheal segment ≥ 3.5 cm, presence of diabetes mellitus and pre-operative use of corticosteroids were statistically significant factors for the onset of complications. Perioperative mortality rate was 1.5% (n = 1). Length of resection > 3.5 cm, presence of diabetes mellitus and pre-operative prolonged use of corticosteroids were significant predictors for the anastomotic complications.

14.
15.
Diagn Cytopathol ; 45(6): 569-573, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28262005

RESUMO

We present an interesting scenario where a 64 years old male presented with a long standing painless, infra-auricular swelling, which had progressively increased in size. Based on the site, the clinical impression was of a salivary gland lesion and FNAC was performed. The smears were unusually cellular and had necrotic background. The cytological diagnosis was a cystic neoplasm of salivary gland, possibly mucoepidermoid carcinoma. Warthin's tumor was also kept in differential. However, the radiological investigations, which were made available after the FNAC report were conflicting with cytological diagnosis of a malignancy and were characteristic of a carotid body tumor, generally a benign neoplasm. Surgical excision of the tumor with regional lymph node sampling was done and histopathological examination solved the puzzle by revealing metastasis of paraganglioma to right posterior triangle lymph nodes. This case is unique because of the unusual presentation of a malignant paraganglioma as an infra-auricular swelling, which was clinically considered as a parotid tumor. The clinician as well as the pathologist need to be aware of such diagnostic pitfall. Diagn. Cytopathol. 2017;45:569-573. © 2017 Wiley Periodicals, Inc.


Assuntos
Tumor do Corpo Carotídeo/patologia , Paraganglioma/patologia , Neoplasias Parotídeas/patologia , Biópsia por Agulha Fina , Diagnóstico Diferencial , Humanos , Metástase Linfática , Masculino , Pessoa de Meia-Idade
16.
J Nephropharmacol ; 6(1): 27-29, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28197527

RESUMO

Cryptococcosis commonly involves central nervous system and lungs in organ transplant recipients. Isolated laryngeal infection is extremely rare. We report a rare case of cryptococcus in a renal allograft recipient that clinically presented with hoarseness of voice and mimicked laryngeal carcinoma on examination.

17.
J Pharm Sci ; 95(11): 2473-85, 2006 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-16886199

RESUMO

The objectives of the present research investigations were to (i) elucidate the mechanism for the oxidative degradation of Delta(9)-tetrahydrocannabinol (THC) in polymer matrix systems prepared by a hot-melt fabrication procedure, and (ii) study the potential for controlling these mechanisms to reduce the degradation of THC in solid dosage formulations. Various factors considered and applied included drug-excipient compatibility, use of antioxidants, cross-linking in polymeric matrices, microenvironment pH, and moisture effect. Instability of THC in polyethylene oxide (PEO)-vitamin E succinate (VES) patches was determined to be due to chemical interaction between the drug and the vitamin as well as with the atmospheric oxygen. Of the different classes and mechanisms of antioxidants studied, quenching of oxygen by reducing agents, namely, ascorbic acid was the most effective in stabilizing THC in PEO-VES matrices. Only 5.8% of the drug degraded in the ascorbic acid-containing patch as compared to the control (31.6%) after 2 months of storage at 40 degrees C. This coupled with the cross-linking extent and adjustment of the pH microenvironment, which seemed to have an impact on the THC degradation, might be effectively utilized towards stabilization of the drug in these polymeric matrices and other pharmaceutical dosage forms. These studies are relevant to the development of a stable transmucosal matrix system for the therapeutic delivery of amorphous THC.


Assuntos
Dronabinol/química , Antioxidantes/química , Química Farmacêutica , Reagentes de Ligações Cruzadas , Estabilidade de Medicamentos , Excipientes , Umidade , Concentração de Íons de Hidrogênio , Oxirredução , Polietilenoglicóis , Polímeros , Termogravimetria , Tocoferóis , Vitamina E/análogos & derivados
18.
J Pharm Sci ; 95(8): 1841-53, 2006 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-16795020

RESUMO

The objective of the present research was to investigate the stability of an amorphous drug, Delta(9)-tetrahydrocannabinol (THC) in polymer-based transmucosal systems. THC was incorporated in polyethylene oxide and hydroxypropylcellulose matrices by a hot-melt fabrication procedure, utilizing various processing aids. The chemical stability of the drug in the polymeric matrices was investigated with respect to processing temperature, processing time, formulation additives, and storage conditions. HPLC analysis of the THC-loaded systems indicated that the extent of drug degradation was influenced by all of the above mentioned variables. THC was particularly unstable in the vitamin E succinate-processed films, indicating a potential incompatibility. Thermal stability of the drug, polymers, and other ingredients at the elevated processing temperatures during the fabrication procedure, was evaluated using the isothermal mode of thermo-gravimetric analysis. When held at 160 and 200 degrees C, the weight percentage of THC decreased linearly as a function of time. Weight loss was controlled by blending the drug with polymers, PEO and HPC, of which PEO was determined to be more effective. Although higher temperatures lowered the polymer melt viscosity, THC and other materials were chemically and thermally unstable at such high temperatures. Due to this, matrix fabrication was found to be favorable at relatively lower temperatures, such as 120 degrees C.


Assuntos
Química Farmacêutica/métodos , Dronabinol/síntese química , Polímeros/síntese química , Dronabinol/análise , Estabilidade de Medicamentos , Polímeros/análise , Temperatura
19.
AAPS PharmSciTech ; 7(3): 71, 2006 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-17025251

RESUMO

This research was conducted in order to fabricate stable polyethylene oxide (PEO)-based transmucosal systems of a Delta(9)-tetrahydrocannabinol (THC) prodrug, a hemisuccinate ester, using a hot-melt method. Since Delta(9)-tetrahydrocannabinol-hemisuccinate (THC-HS) was heat labile, a series of processing aids were evaluated in order to facilitate hot-melt production at lower temperatures, thereby reducing THC-HS degradation. The stability of THC-HS was influenced both by the processing conditions such as heating time and temperature, and the postprocessing storage conditions. The type of formulation additive also affected the extent of degradation. In the presence of polyethylene glycol (PEG)-400, the percentage of relative degradation of THC-HS to THC was 13.5% and 49.4% at 80 degrees C and 120 degrees C, respectively. In contrast, incorporation of vitamin E succinate (VES) reduced processing degradation to 2.1% and 9.2%, respectively, under the same conditions. Severe degradation of THC-HS was observed during storage, even under freezing conditions (-18 degrees C). A VES-Noveon AA-1 combination was observed to best stabilize the prodrug systems both during processing and postprocessing. Stabilization of THC-HS was achieved in these polyethylene oxide matrices at 4 degrees C, with almost 90% of theoretical drug remaining for up to 8 months. Investigation of the pH effect revealed that the pH of the microenvironment in these polymeric systems could be modulated to significantly improve the stability of THC-HS, degradation being the least in a relatively acidic medium.


Assuntos
Dronabinol/administração & dosagem , Pró-Fármacos/administração & dosagem , Portadores de Fármacos , Sistemas de Liberação de Medicamentos , Estabilidade de Medicamentos , Concentração de Íons de Hidrogênio , Polietilenoglicóis/química , Tecnologia Farmacêutica , Temperatura , Tocoferóis , Vitamina E/administração & dosagem , Vitamina E/análogos & derivados
20.
AAPS PharmSciTech ; 7(3): E114-E125, 2006 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28290012

RESUMO

This research was conducted in order to fabricate stable polyethylene oxide (PEO)-based transmucosal systems of a Δ9-tetrahydrocannabinol (THC) prodrug, a hemisuccinate ester, using a hot-melt method. Since Δ9-tetrahydrocannabinol (THC-HS) was heat labile, a series of processing aids were evaluated in order to facilitate hot-melt production at lower temperatures, thereby reducing THC-HS degradation. The stability of THC-HS was influenced both by the processing conditions such as heating time and temperature, and the postprocessing storage conditions. The type of formulation additive also affected the extent of degradation. In the presence of polyethylene glycol (PEG)-400, the percentage of relative degradation of THC-HS to THC was 13.5% and 49.4% at 80°C and 120°C, respectively. In contrast, incorporation of vitamin E succinate (VES) reduced processing degradation to 2.1% and 9.2%, respectively, under the same conditions. Severe degradation of THC-HS was observed during storage, even under freezing conditions (-18°C). A VES-Noveon AA-1 combination was observed to best stabilize the prodrug systems both during processing and postprocessing. Stabilization of THC-HS was achieved in these polyethylene oxide matrices at 4°C, with almost 90% of theoretical drug remaining for up to 8 months. Investigation of the pH effect revealed that the pH of the microenvironment in these polymeric systems could be modulated to significantly improve the stability of THC-HS, degradation being the least in a relatively acidic medium.

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