Incidence of postoperative pain after using single continuous, single reciprocating, and full sequence continuous rotary file system: a prospective randomized clinical trial

Background@#Extrusion of debris is a major factor that results in postoperative pain during root canal treatment with various instruments and instrumentation techniques. Therefore, instrumentation techniques that extrude minimal debris into the periapical area while reducing pain are desirable. This study aimed to compare the incidence of postoperative pain and intake of analgesic medication (frequency and quantity) after endodontic treatment of mandibular posterior teeth using two single files and full-sequence continuous rotary systems with different kinematic motions. @*Methods@#Thirty-five of 105 patients were assigned equally to three groups according to the instrumentation system used: ProTaper Next (PN) X2, 25/06 (Dentsply, Maillefer, Ballaigues, Switzerland), One Shape (OS), #0.25/06 (Micro Mega, Besancon, France), and Wave One Gold (WG), Red - #0.25, 0.07 (Dentsply, Maillefer, Ballaigues, Switzerland). Five specialists were included in this study design; each professional prepared 21 teeth, and randomly selected 7 per instrument system. The VAS sheet ranging from 0 to 10 was used to record the initial and postoperative pains at 24, 48, and 72 h, and 7th day after single visit endodontic treatment in mandibular premolars and molars with a diagnosis of asymptomatic irreversible pulpitis with or without apical periodontitis. Postoperatively, an analgesic, ibuprofen 400 mg was administered for intolerable pain at a dose of 1 tablet for 6 h. The patients were asked over the telephone regarding postoperative pain at intervals of 24, 48, and 72 h, and 7 th day using a visual analogue scale.Result: There were no statistically significant differences among the PN, OS, and WG systems (P > 0.05) with regard to the incidence of postoperative pain at any of the four time points assessed. @*Conclusion@#The intensity of postoperative pain, frequency, and analgesic intake were similar across all three types of instrument systems; however, the reciprocating single file (WG) was associated with less postoperative pain than the full sequence continuous rotary file.

Does the presence and amount of epinephrine in 2% lidocaine affect its anesthetic efficacy in the management of symptomatic maxillary molars with irreversible pulpitis?

Background@#This was a randomized controlled clinical trial that aimed to evaluate the anesthetic efficacy of 2% lidocaine combined with different concentrations of epinephrine (plain, 1:200,000 and 1:80,000) during endodontic treatment of maxillary molars with symptomatic irreversible pulpitis. @*Methods@#The trial included 144 adult patients who were randomly allocated to three treatment groups. All patients received buccal-plus-palatal infiltration. After 10 min, pulp sensibility testing was performed using an electric pulp test (EPT). If a tooth responded positively, anesthesia was considered to have failed. In the case of a negative EPT response, endodontic access was initiated under rubber dam isolation. The success of anesthesia was defined as having a pain score less than 55 on the Heft Parker visual analog scale (HP VAS), which was categorized as ‘no pain’ or ‘faint/weak/mild’ pain on the HP VAS. Baseline pre-injection and post-injection maximum heart rates were recorded. The Pearson chi-square test was used to analyze the anesthetic success rates at 5% significance. @*Results@#Plain 2% lidocaine and 2% lidocaine with 1:200,000 epinephrine and 1:80,000 epinephrine had anesthetic success rates of 18.75%, 72.9%, and 82.3%, respectively. Statistical analysis indicated significant differences between the groups (P < 0.001, χ2 = 47.5, df = 2). The maximum heart rate increase was seen with 2% lidocaine solution with epinephrine. @*Conclusion@#Adding epinephrine to 2% lidocaine significantly improves its anesthetic success rates during the root canal treatment of maxillary molars with symptomatic irreversible pulpitis.

Addition of 2 mg dexamethasone to improve the anesthetic efficacy of 2% lidocaine with 1:80,000 epinephrine administered for inferior alveolar nerve block to patients with symptomatic irreversible pulpitis in the mandibular molars: a randomized double-blind clinical trial

Methods@#In a double-blinded setup, 124 patients randomly received either of the following injections: 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, or plain 2% lidocaine mixed with 2 mg dexamethasone, which were injected as a primary IANB. Ten minutes after injection, patients with profound lip numbness underwent electric and thermal pulp sensibility tests. Patients who responded positively to the tests were categorized as “failed” anesthesia and received supplemental anesthesia. The remaining patients underwent endodontic treatment using a rubber dam. Anesthetic success was defined as “no pain or faint/weak/mild pain” during endodontic access preparation and instrumentation (HP visual analog scale score < 55 mm). The effect of the anesthetic solutions on the maximum change in heart rate was also evaluated. The Pearson chi-square test at 5% and 1% significance was used to analyze anesthetic success rates. @*Results@#The 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, and plain 2% lidocaine mixed with 2 mg dexamethasone groups had anesthetic success rates of 34%, 59%, and 29%, respectively. The addition of dexamethasone resulted in significantly better results (P < 0.001, χ 2 = 9.07, df = 2). @*Conclusions@#The addition of dexamethasone to 2% lidocaine with epinephrine, administered as an IANB, can improve the anesthetic success rates during the endodontic management of symptomatic mandibular molars with irreversible pulpitis.

Effect of pre-operative medication with paracetamol and ketorolac on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a double-blind randomized clinical trial

Background@#The efficacy of local anesthesia decreases in patients with symptomatic irreversible pulpitis. Therefore, it was proposed that the use of premedication with an anti-inflammatory drug might increase the success rate of pulpal anesthesia in mandibular posterior teeth with vital inflamed pulp. @*Methods@#One hundred thirty-four patients who were actively experiencing pain willingly participated in this study. The Heft Parker (HP) visual analog scale (VAS) was used to record the initial pain intensity. Patients were randomly allocated to receive a placebo, 10 mg of ketorolac, and 650 mg of paracetamol. The standard inferior alveolar nerve block (IANB) was administered to all patients using 2% lidocaine with 1:200,000 adrenaline after one hour of medication. After 15 min, the patient was instructed to rate the discomfort during each step of the treatment procedure, such as access to remaining dentin, access to the pulp chamber, and during canal instrumentation on the HP VAS. IANB was considered successful if the patient reported no or mild pain during access preparation and instrumentation. Moderate or severe pain was classified as a failure of IANB and another method of anesthesia was used before continuing the treatment. @*Results@#The rate of successful anesthesia in the placebo, paracetamol, and ketorolac groups was 29%, 33%, and 43%, respectively, and no statistically significant difference was found between the groups. @*Conclusion@#Preoperative administration of paracetamol or ketorolac did not significantly affect the success rate of IANB in patients with irreversible pulpitis. No significant difference was observed between the paracetamol and ketorolac groups.

Effect of pre-operative medication with paracetamol and ketorolac on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a double-blind randomized clinical trial

Background@#The efficacy of local anesthesia decreases in patients with symptomatic irreversible pulpitis. Therefore, it was proposed that the use of premedication with an anti-inflammatory drug might increase the success rate of pulpal anesthesia in mandibular posterior teeth with vital inflamed pulp. @*Methods@#One hundred thirty-four patients who were actively experiencing pain willingly participated in this study. The Heft Parker (HP) visual analog scale (VAS) was used to record the initial pain intensity. Patients were randomly allocated to receive a placebo, 10 mg of ketorolac, and 650 mg of paracetamol. The standard inferior alveolar nerve block (IANB) was administered to all patients using 2% lidocaine with 1:200,000 adrenaline after one hour of medication. After 15 min, the patient was instructed to rate the discomfort during each step of the treatment procedure, such as access to remaining dentin, access to the pulp chamber, and during canal instrumentation on the HP VAS. IANB was considered successful if the patient reported no or mild pain during access preparation and instrumentation. Moderate or severe pain was classified as a failure of IANB and another method of anesthesia was used before continuing the treatment. @*Results@#The rate of successful anesthesia in the placebo, paracetamol, and ketorolac groups was 29%, 33%, and 43%, respectively, and no statistically significant difference was found between the groups. @*Conclusion@#Preoperative administration of paracetamol or ketorolac did not significantly affect the success rate of IANB in patients with irreversible pulpitis. No significant difference was observed between the paracetamol and ketorolac groups.

Understand the risk factors associated with non alcoholic fatty liver disease and changes in biochemical parameters in the patients: a prospective study

Background: The true prevalence of both NAFLD and NASH are elusive but estimates based on imaging and autopsy studies suggest that about 20-30% of the adults in United States and western countries have excess fat accumulation in the liver. About 10% of these, strictly speaking about 2-3% of the adult population fulfils the criteria of NASH. True prevalence of NAFLD in Indian patients is not known. So, this study was planned to look for current trend of NAFLD in Indian patients.Methods: This prospective observational study was conducted in the Department of Medicine on 65 patients with ultra-sonography finding of fatty liver disease with no history of alcohol, in one year study duration.Results: It is observed that maximum patients are of middle age from age 31-60 years comprising 76% of patients. Out of total patients, 34% and 66% were males and females respectively. Out of 65 patients, 45(69%) had obesity and maximum number of the patients had waist hip ratio and neck circumference more than the cut off value. Out of 65 patients, 19(29%) had hypercholesterolemia and 42(65%) had hyper-triglyceridemia. Out of 65 patients, 32(49%) had higher alanine transaminase (ALT) level and 17(29%) patients had higher AST level. Out of 65 patients, 29(45%) had the homeostasis model assessment of insulin resistance (HOMA-IR) less than cut off value (less than 2.25) and remaining 36(55%) were having HOMA-IR more than 2.25. The sensitivity for the cut off value for HOMA-IR is 72.7% and specificity is 49.1%.Conclusions: Obesity, neck circumference, and waist hip ratio are higher than its cut off value for both sex, insulin resistance evaluated through HOMA- IR directly relates to the causation of NAFLD but at some extents higher triglyceride levels are also associated but the values of ALT and AST levels did not give any clue in these cases of NAFLD.

A study of prevalence of migraine in stroke patients and its association with ischemic versus hemorrhagic stroke: a cross sectional study

Background: Migraine is characterized by recurrent attacks of disabling headache and autonomic nervous system dysfunction. Up to one third of patients also have neurological aura symptoms. It has been suggested that migraine can be a risk factor for stroke. Migraine affects three times the number of women than men. The incidence of stroke in men is two times that of women. It is shown in several studies that women aged 35 to 45 years old are at increased risk of ischemic stroke who had migraine with or without aura.Methods: The present cross sectional study was conducted in 350 consecutive patients of stroke who were attended OPD and admitted in wards of the Department of Medicine, M.G.M. Medical College and MY Hospital, Indore, MP, India, during period from December 2017 to December 2018.Results: The highest percentage of respondents i.e. 68% belonged to male group followed by 32% of respondents who were females. The highest percentage of respondents i.e. 66.6% had ischemic stroke while, 33.4% had hemorrhagic stroke. The highest percentage of respondents i.e. 90.9% had no Migraine while, 9.1% had Migraine. The highest percentage of respondents i.e. 31.2% had weekly reoccurrence, followed by forth nightly (25%) and lowest was 3.1% of daily recurrence. The association of type of stroke with sex group of patient’s history of headache which found to be significant (p ?0.05). The association of type of stroke with sex group of patient’s history of various cerebro-vascular risk factors which found to be significant (p<0.05). Patients having hemorrhagic and ischemic stroke also had HTN in 47% and 12.4% patients respectively.Conclusions: In this study it is concluded that migraine can be established as a risk factor for ischemic stroke. Early diagnosis and treatment with available medication can be helpful in prevention or decreasing risk for developing stroke.

A study of serum thyroid stimulating hormone levels, and its correlation with clinical features and delayed diagnosis of hypothyroidism in central India

Background: The clinical manifestations of hypothyroidism are variable, depending upon its cause, duration and severity. The spectrum extends from subclinical to overt hypothyroidism to myxedema coma. A high degree of suspicion is thus required in order to appreciate the clinical manifestation of the disorder to reach a diagnosis. Purpose of this study was to correlate serum TSH level with severity of clinical manifestations and evaluate possible cause of delay in the diagnosis.Methods: A cross section observational and descriptive study for the assessment of severity of primary hypothyroidism at presentation and evaluation of the causes of delay in diagnosis in 86 patients was done from December 2012 to November 2013 in the Department of Medicine, MGM Medical College, Indore, MP, India.Results: Illiterate patients had significantly (p value 0.002) higher TSH values at presentation. 34.8% of patients presented as severe hypothyroidism with TSH value >100 mIU/L. Delay of as much as 7 years was noted. Majority of patients had a delay of around 1 to 3 years in diagnosis. Only 4.6% patients were diagnosed without any delay due to high level of suspicion at presentation.Conclusions: Due to non-specific symptomatology of hypothyroidism diagnosis is often delayed. Therefore, high index of suspicion is required at the physician抯 level and test of thyroid function is available at subsided cost therefore it should be offered to all such patients.

Paresthesia diagnosed using cone-beam computedtomography: a case report

Various dental procedures, such as injection administration, surgical treatment, and endodontic treatment, cancause injury to the nerves. The most commonly injured nerves are the inferior alveolar and lingual nerves.This can manifest as altered sensation to the area of innervation of the injured nerve, such as the lower lip,chin, teeth, tongue, and mucosa. Altered sensations or loss of sensation are relatively infrequent complicationsin daily dental practice. Here, we report an uncommon case of altered sensation in the midfacial region causedby an endodontic procedure and discuss the need to consider local dental causes in the differential diagnosisof numbness in the facial region.

A study of effect of low dose atorvastatin therapy on high sensitivity C-reactive protein in patients with modifiable and non-modifiable cardiovascular risk factors in central India

Background: Anti-inflammatory effects of statins have generated maximum interest, as has been demonstrated in a number of studies showing rapid decrease in CRP levels in patients of acute coronary syndromes. This CRP lowering property of statins has also translated into clinical benefits as suggested by reduction in rate of recurrent angina, recurrent myocardial infarction, and mortality.Methods: This prospective, open, and controlled study was conducted on 160 indoor and outdoor patients, for total duration of two years (2005-2006), in GMC Bhopal, MP, India.Results: In all the four groups, baseline serum hs-CRP was statistically significant (p value <0.01) higher than normal hs-CRP level. Mean reduction (%) in hs-CRP after 3 months of statin therapy was 83.6% in group A and 62.4% in group C which is highly significant (p value <0.001). In group B also, 26% hs-CRP reduction was noticed which is statistically significant (p value <0.01). Baseline hs-CRP was statistically significant high (p value <0.01) in hypertensive patients. Percentages reduction in group A (87%) and group C (66%) was statistically significant (p value <0.01). Baseline hs-CRP was statistically significant higher (p value <0.01) than normal population. After 3 months of statin therapy percentage reduction in group A and group C was statistically significant (p value <0.01). Conclusions: Low dose atorvastatin can significantly reduce CRP level in patients with risk factors for cardiovascular disease. Early initiation of low dose atorvastatin can reduce this inflammatory marker in both ACS and high risk for ACS patients and can prevent major adverse cardiac events.

Comparsion of Palonsteron, Ondansetron and Dexamethasone in Reduction of Post Operative Nausea and Vomiting Following Laparoscopic Cholecystectomy

The aim of the study is to compare efficacy of intravenous (i/v) Palonosetron (75mcg), i/v Ondansetron (4mg) and i/v Dexamethasone (5mg) as prophylactic agents for reducing post-operative nausea and vomiting that follows laparoscopic cholecystectomy. Methods: This prospective randomized double blind study was conducted in the Department of Anaesthesia and Critical Care, Tata Main Hospital, Jamshedpur. The study participants comprised of patients undergoing elective laparoscopic cholecystectomy surgeries under general anaesthesia. A total of 90 patients i.e. 30 in each of the three groups were enrolled for the study. Enrolled patients were randomly allocated to received with i/v Dexamethasone (5 mg) or i/v Ondansetron (4mg) or i/v Palonosetron (0.075 mg). The patients in the three groups were monitored and symptoms charted on basis of Post Operative Nausea and Vomiting (PONV) scale. Results: Palonosetron 0.075mg single intravenous dose given prior to induction of anaesthesia achieves 100% complete response with 3.33% reported side effect, and none needed rescue antiemetic. Dexamethasone 5mg single intravenous dose given prior to induction of anaesthesia achieves 93.33 % complete response with none reporting side effect and 6.67% needing rescue antiemetic. Ondansetron 4mg single intravenous dose given prior to reversal of neuromuscular blockade achieves 66.67 % complete response with 20% reporting side effect and 33.33 % needing rescue antiemetic. Conclusion: I.V. Palonosetron and Dexamethasone are equally potent and superior antiemetics than Ondansetron in the prevention of PONV in patients undergoing elective laproscopic cholecystectomy under general anaesthesia.

Gall Bladder Metaplasia: Its Prevalence And Correlation With Dysplasia And Carcinoma

Background: Gallstones are the most common biliary pathology. Gall bladder metaplasia has been cited as precursor lesion of dysplasia and therefore carcinoma. The aim of study was to assess the prevalence of gallbladder metaplasia due to underlying cholelithiasis and to establish its correlation with dysplasia and carcinoma. Materials and methods: All the post cholecystectomy samples during 1 year period from October 2017 to September 2018 submitted for histopathology comprised the study material. Results: Total 359 cases were included, of which metaplasia was seen 152(42.3%). Antral metaplasia is commonest 104 (29.0%) followed by combined metaplasia cases 34 (9.5%) and than intestinal only cases in 14(3.9%). Significant correlation was seen between intestinal metaplasia to antral metaplasia and dysplasia. Conclusion: Very high prevalence of metaplasia was observed. Antral metaplasia was more frequent than combined metaplasia followed by intestinal alone. Intestinal metaplasia was statistically correlated to dysplasia.

A Study to Know the Effect of Antiepileptic Drugs on Liver Enzymes

Objective: To know the effect of antiepileptic drugs on liverenzymes.Study Design: Cross sectional study.Materials & Methods: The study was conducted on 108patients at SIMS Hapur and G.S Medical College Hapurbetween Jan 17 to Dec 17. Patients divided into 3 groups,consisting of 36 patients in each group of phenytoin,carbamazepine and valproate.Results: Total No. of Patients was 108, out of which 36patients were there is each group of Phenytoin,Carbamazepine and valproate. Most of the patients 36(33.33%) and 32 (29.62%) belongs to age group of >40 – 50years and >50 year respectively. Regarding raised SGPT, itwas seen in 5 (13.89), 3 (8.33) and 3 (8.33) in phenytoin,carbamazepine and sodium valproate group respectively.SGOT were raised in sodium valproate group respectively.Alkaline phosphatase were raised in 10 (27.78), 20 (55.56) and22 (61.11) in phenytoin group, carbamazepine group, andsodium valproate group respectively.Conclusion: From the present study we can conclude thatsodium valproate is more hepatotoxic than carbamazepinewhich is more toxic than phenytoin. It is recommended thatbase line Liver Function Test (LFT) is essential before startingof AEDs and regular monitoring of LFT is also done betweenthe course of treatment.

Profile of organo phosphorous poisoning at a tertiary medical centre in Jharkhand, India

Background: Poisoning is the most common method, employed for the act of deliberate self-harm. The wide availability, lack of rules and regulations for the sale of pesticides resulted in wide spread use of Organophosphate as one of the most common poison used for deliberate self-harm.Methods: In this study, authors aim to find out clinical profile with respect to different O.P. compounds, prognosis and outcome of each patient in relation to the delay in getting medical attention. Present study objective is to find out if there is any specific clinical finding which can predict bad outcome.Results: Out of 344 cases, 189 cases had type 1 respiratory failure, while in 34 cases type II respiratory failure present. 61 cases expired and out of these 61 cases 47 cases died within 24 hours and 11 cases died in next 48 hours.Conclusions: Maximum number of cases were in the age group of 21 - 30years. The maximum number of deaths were in the first 72 hours. Number of cases were more in males as compared to females. Chances of survival was better in persons who reached early to the hospital.

Vitamin D Estimation: A New Biomarker for Cardiovascular Disease

Background: Vitamin D deficiency is prevalent in the majority parts of the world. The prevalence of vitamin D deficiency in India in urban area 9-11% and in rural area 3-6%. Coronary artery disease is worldwide health problem and consists of variety of heart illness. Vitamin D deficiency may cause cardiovascular events by a variety of potential biological mechanism. Aims & Objectives: To evaluate the role of vitamin D as a rising risk factor for coronary artery disease.  Materials & Methods: The study was carried out in department of Cardiology, S.P. Medical College included 50 patients of coronary artery disease admitted in H.R.M. Center Bikaner. The control population comprise of age and sex matched 50 healthy persons. Vitamin D was done on ELISA reader and lipid profile assessment was done on fully automated analyzer. The statistical analysis was done by using SPSS software. The results were articulated as Mean ± SD. The Student t-test was carried out for relationship of the data & P value <0.05 was considered statistically significant. Results: The study discovered that vitamin D level was established to be significantly lower in cases as compared to controls. We also noticed significant difference in mean to total cholesterol, HDL cholesterol and LDL cholesterol in between cases and control. Conclusion: This study concluded that continue follow up of vitamin D will be helpful for measurement of increased risk of coronary artery disease episode beyond the traditional risk factors.

Comparison of caudal dexmedetomidine and fentanyl combined with bupivacaine in pediatric patients undergoing urogenital surgery

Introduction: Caudal epidural block is one of the most popular, reliable, and safe techniques in pediatric patients that can provide analgesia for a variety of supra- and infra-umblical surgical procedures. This study aimed to compare the efficacy of dexmedetomidine-bupivacaine, fentanyl-bupivacaine mixture and bupivacaine alone on duration of postoperative analgesia, sedation, emergence agitation, duration of sensory and motor block, hemodynamic stability and side effects

Methodology: After approval from ethical committee 90 pediatric patients of age 2-7 y were enrolled. The children were randomly allocated to three equal groups of 30 each using a computer generated randomization list. Caudal block was given after induction of general anesthesia for urogenital surgery. General anesthesia was maintained with sevoflurane at a concentration adjusted to maintain BIS between 40-60. Hemodynamic parameters, Pediatric Anaesthesia Emergence Delirium [PAED] score, Richmond agitation sedation scale [RASS], and Children's Hospital of Eastern Ontario Pain Scale [CHEOPS] were recorded immediate postoperatively and then regularly every hour for the next 12 hours

Results: PAED score was less in group BD than group B and BF from baseline. RASS Score was less in Group BD than Group BF from base line to 12 h except at 240 min and Group BF is less than Group B from base line to 12 h. Group BD was less than B from base line to 12 h. CHEOP score was less in Group BD than Group BF and Group B from base line to 12 h

Conclusion: Dexmedetomidine [1 micro g/kg] added to bupivacaine in caudal block increases the duration of postoperative analgesia, provides arousable sedation, and decreases emergence delirium with stable hemodynamics and minimal side effects in pediatric patients

Elbow dislocation with ipsilateral diaphyseal forearm bone fracture: A rare injury report with literature review / 中华创伤杂志(英文版)

Dislocation of the elbow along with shaft fractures of both bones of the ipsilateral forearm is a rare injury though elbow dislocation or fracture of the forearm bones may occur separately. Such injuries need a concentric reduction of the dislocation and an anatomical fixation of forearm bones for optimal functional outcomes. We report a case of elbow dislocation with fracture of the lateral condyle of the humerus along with fractures of shafts of the radius and ulna in a 44-year-old female. Closed reduction of the elbow and operative stabilization of all fractures were done with good clinical, radiological and functional outcomes in 2 years follow-up period. A significant degree of force is needed to produce a combined dislocation of a joint and fracture of bones around that joint and these complex injuries may be missed if the clinician is not aware of the possibility of such injuries. The fact that the previously reported cases had a posterolateral dislocation while our case had a posteromedial dislocation and a fracture of the lateral humeral condyle as well makes it unique in its presentation and worth reporting. We have also included an up to date literature review on this topic.

Bilateral central acetabular fracture dislocation in a young patient due to seizure activity: a case report and review of the literature / 中华创伤杂志(英文版)

Various musculoskeletal injuries are well known complications of epilepsy either because of direct trauma or because of unbalanced forceful muscle contraction. We report a case of non-traumatic bilateral central acetabular fracture dislocation due to seizure activity induced by neurocysticercosis of the brain, which was managed conservatively and obtained reasonable good outcome. This case highlights the importance of proper evaluation in young non-osteoporotic patients who have experienced an epileptic attack without any previous history. It is also imperative to mention that these patients should be thoroughly examined neurologically to find out the exact etiology and should be treated accordingly to prevent future seizure activity.

Antilithiatic activity of poly-herbal formulation tablets by in-vitro method.

Hydroalcoholic extracts of Kalanchoe pinnata and Rotula aquatica and its combination were formulated herbal tablets, evaluated for antilithiatic in vitro method. The homogenous precipitation method was used. The study was carried out in glass tubes. The buffer system used was TRIS buffer pH 7.4. The experiment consists of the following tubes for control and test, 25 ml each of 25 mM CaCl2. 2H2O, 25 mM Na2HPO4. 2H2O or 25mM Na2C2O4. To the tubes of each set, tablet formulation or an equal amount of vehicle was added. The tubes were incubated at 37°C for 4 h. The precipitate of calcium phosphate was generated by mixing 1 ml of solution from the tubes having calcium chloride dihydrate and disodium hydrogen phosphate monohydrate and Calcium oxalate precipitate was generated by mixing 1 ml of solutions from the tubes having calcium chloride dihydrate and sodium oxalate solutions. Calcium was estimated using titrimetry and phosphorus was estimated using colorimetric analysis. Appropriate standard curves were done with each set of experiments. The amounts of precipitate of calcium and phosphate were determined in each of the respectively. The percent inhibition of the test was calculated in comparison with the control samples. Herbal tablet formulation showed antilithiatic activity to the marketed formulation in terms of inhibiting the formation of phosphate precipitate but showed a significantly better potential in preventing the formation of the calcium precipitate. The herbal tablet formulation of Kalanchoe pinnata and Rotula aquatica have inhibitory effect on calcium oxalate crystallization thus may be beneficial in the treatment of renal lithiasis.

A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations

A stability-indicating high-performance liquid chromatographic (HPLC) method was developed with short run time and validated for the assay of process related impurities of pantoprazole in bulk form. Resolution of drug, its potential impurities and degradation products were achieved on a Hypersil ODS column utilizing a gradient with 0.01 M phosphate buffer of pH 7 and acetonitrile as eluent, at the detection wavelength of 290 nm. Flow rate was set at 1 mL min-1. The procedure was found to be specific, linear (r=0.999), recovery (97.9-103%), LOD (0.043-0.047 µgmL-1), LOQ (0.13-0.14 µgmL-1) and robust. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations. Pantoprazole was found to degrade in acidic, oxidative and under photolytic stress conditions. The drug was stable to alkaline and dry heat conditions. This method has been successively applied to pharmaceutical formulation and no interference from the excipients was found.

Desenvolveu-se método indicador de estabilidade por Cromatografia a Líquido de Alta Eficiência (CLAE) com pequeno tempo de corrida e validado para o ensaio de impurezas relacionadas ao processo de produção de pantoprazol em batelada. A determinação do fármaco, de suas impurezas potenciais e dos produtos de degradação foi realizada com coluna de ODS Hypersil, utilizando gradiente com tampão de fosfato 0,01 M pH 7 e acetonitrila como eluente, no comprimento de onda de detecção de 290 nm. A velocidade de fluxo foi fixada em 1 mLmin-1. O procedimento se mostrou específico, linear (r=0,999), com recuperação (97,9-103%), LOD (0,043-0,047 µgmL-1), LOQ (0,13-0,14 µg mL-1) e robusto. Robustez aceitável indica que o método de ensaio não é afetado por variações pequenas, exceto as planejadas. O pantoprazole degradou em condições ácidas, oxidativas e sob condições de estresse fotolítico. O fármaco foi estável em condições alcalinas e de calor seco. Este método tem sido sucessivamente aplicado à formulação farmacêutica e não se encontrou interferência de excipientes.