Paracetamol Tablets Research Articles

Perioperative pregabalin for acute and chronic pain after abdominal hysterectomy or myomectomy

The antiepileptics gabapentin and pregabalin are used as adjuvants to control postoperative pain. The aim of the present study was to investigate the effect of perioperative administration of pregabalin on postoperative acute and chronic pain and analgesic requirements. Department of Anaesthesiology, Aretaieio University Hospital, Athens, Greece. Eighty patients scheduled for abdominal hysterectomy or myomectomy were randomly assigned to the pregabalin or to the control group. The pregabalin group received 150 mg of pregabalin 8-hourly, starting on the afternoon before surgery and continued until the fifth postoperative day. The control group was similarly treated, but received placebo capsules instead. Postoperative intravenous morphine and Lonalgal (30 mg codeine with 500 mg paracetamol) tablet consumption, visual analogue pain scores at rest and on coughing, sedation, anxiety, dizziness, ataxia, blurred vision and diplopia were recorded. One and 3 months postoperatively patients were interviewed for the presence of pain and analgesic needs due to surgery. The pregabalin-treated patients consumed less morphine during the first 48 h postoperatively (P = 0.0001). However, consumption of Lonalgal tablets and visual analogue scores for pain at rest and on coughing did not differ between the groups. No difference was found in sedation and anxiety scores between the patients who received placebo or pregabalin. Patients in the control group had lower incidences of dizziness (29 versus 58%, P = 0.015), ataxia (0 versus 18%, P = 0.011), blurred vision (6 versus 26%, P = 0.028) and diplopia (0 versus 16%, P = 0.023). Presence of pain, analgesic intake due to surgery and decreased or absent sensation around the wound did not differ between the groups 1 and 3 months postoperatively. Pregabalin in the doses given decreased morphine requirements for the first 48 h postoperatively, but neither altered the analgesic requirements beyond 48 h nor had any effect on acute, late or chronic pain.

Pulsatile dry cupping in patients with osteoarthritis of the knee – a randomized controlled exploratory trial

IntroductionCupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA).MethodsIn a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome.Results21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9).ConclusionIn this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed.Trial registrationClinicaltrials.gov Identifier: NCT01057043

Comparative Evaluation of the Biopharmaceutical and Chemical Equivalence of the Some Commercial Brands of Paracetamol Tablets

Comparative Evaluation of the Biopharmaceutical and Chemical Equivalence of the Some Commercial Brands of Paracetamol Tablets

Physicochemical and dissolution profile characterization of pellets containing different binders obtained by the extrusion-spheronization process

With the purpose of evaluating the behavior of different polymers employed as binders in small-diameter pellets for oral administration, we prepared formulations containing paracetamol and one of the following polymers: PVP, PEG 1500, hydroxypropylmethylcellulose and methylcellulose, and we evaluated their different binding properties. The pellets were obtained by the extrusion/spheronization process and were subsequently subjected to fluid bed drying. In order to assess drug delivery, the United States Pharmacopeia (USP) apparatus 3 (Bio-Dis) was employed, in conjunction with the method described by the same pharmacopeia for the dissolution of paracetamol tablets (apparatus 1). The pellets were also evaluated for granulometry, friability, true density and drug content. The results indicate that the different binders used are capable of affecting production in different ways, and some of the physicochemical characteristics of the pellets, as well as the dissolution test, revealed that the formulations acted like immediate-release products. The pellets obtained presented favorable release characteristics for orally disintegrating tablets. USP apparatus 3 seems to be more adequate for discriminating among formulations than the basket method.

Paracetamol use (and/or misuse) in children in Enugu, South-East, Nigeria.

BackgroundParacetamol (also known as acetaminophen) is the commonest available analgesic and anti-pyretic. It is readily accessed from pharmacy, patent medicine and provision shops as over the counter drug making it a potential drug of abuse, especially in children. We sought to find its use and/or misuse in children seen at the paediatric outpatient clinic of the University of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla, Enugu.ObjectiveTo determine the dosage, formulation, and frequency of paracetamol administration to children by caregivers and factors associated with its use and/or misuse.MethodAn observational prospective study involving 231 children and their caregivers seen at the paediatric outpatient clinic of the University of Nigeria Teaching Hospital, Ituku - Ozalla, Enugu between June and November 2011 was undertaken. Data on paracetamol use before presentation to the clinic, in addition to demographic and other data were obtained from the caregivers using a structured questionnaire. Ethical consent for the study was obtained from the Hospital Ethics and Research Committee and informed consent was further obtained from the caregivers of the children.ResultsA total of 231 children aged six weeks to 16 years and their caregivers participated in this study. The mean ages of the children and their caregivers were 3.8 and 33.9 years, respectively. One hundred and thirty three of the children studied were males while 98 were females. Most of the children (75.6%) received paracetamol at home before presenting. Paracetamol tablet alone or in combination with the syrup was mostly used (60%) and this observation was made across all age groups. The commonest reason for using paracetamol tablet instead of the syrup was that it was more effective. Most caregivers relied on past experience (71.2%) rather than on enclosed information leaflet to decide the appropriate dosage. Half of the children also received other medications, mainly anti-malarials and antibiotics.ConclusionsParacetamol was commonly given to children on “self prescription” basis and the tablet formulation was most frequently used, with the possibility of misuse and overdose. Caregivers need to be educated on age-appropriate formulations which are less likely to lead to overdose.

Kandidias Oral pada Penderita Anemia Defisiensi Besi (Fe) dan Penetalaksanaannya

Background: Iron deficiency anemia is a microcytic anemia caused by chronic blood loss dueto such problems as excessive menstrual flow, gastrointestinal bleeding, gasterektomi or malabsorption that reduces the absorption of Fe. Predisposing factors that lead to the disruption of the ecology of oral candidiasis or oral microbiological changes can be due to malnutrition (iron deficiency, folic acid, vitamin B12) and the very old age. Objective: To report a case of iron deficiency anemia with oral candidiasis and its management. Case Report: A 69-year man in the reference by peer demonstrated swollen gums, mouth pain and difficulty in swallowing. A moth ago he was hospitalized and boarded for a week but no change, his body weight loss was 25kg. paleconjunctiva and face, droliing, looked weak. The body temperature was 370 C; the BP measurement was: 125/80mmHg; with body weight was 50kg; right and left submandibular lymph nodes become enlarging and soreness palpatiom. Symmetrical face. Right and left lip corners are angular kheilitis, cheek mucosa, palate hyperemia, gingival stipling was disappeared, hyperemia, dorsal surface smooth tongue, hyperemia, depapilasi, OHI: bad; thick saliva, hypersalivation. A lot of dental caries and the remaining roots. Management: Examination of the saliva with KOH solution looked a hyphe. Routine blood tests and profile of fe all within normal limits except RBC was 3,37.106 / uL; HGB: 11.0 g / dl; HCT: 32.2%, Fe 29.00 u g / dl (below normal). Treatment with 3% perhidrol mouthwash, Nyistatin solution 3 x daily. Zegase tablet 2x daily. Paracetamol tablets if necessary. Conclusion sixteen days later the patient recovered.

Surface analysis using a new plasma assisted desorption/ionisation source for mass spectrometry in ambient air

The authors report on a modified micro-plasma assisted desorption/ionisation (PADI) device which creates plasma through the breakdown of ambient air rather than utilising an independent noble gas flow. This new micro-PADI device is used as an ion source for ambient mass spectrometry to analyse species released from the surfaces of polytetrafluoroethylene, and generic ibuprofen and paracetamol tablets through remote activation of the surface by the plasma. The mass spectra from these surfaces compare favourably to those produced by a PADI device constructed using an earlier design and confirm that the new ion source is an effective device which can be used to achieve ambient mass spectrometry with improved spatial resolution.

Albizia procera gum as an excipient for oral controlled release matrix tablet

The purpose of this research was to develop and evaluate controlled release matrix tablets of paracetamol based on natural gum exudates of Albizia procera. Procera gum was characterized of its properties like compressibility index, angle of repose, viscosity and moisture content. The interaction between the gum and paracetamol was also studied through differential scanning calorimetry (DSC) and FTIR spectroscopy. Matrix tablets were then prepared by wet granulation method with different concentrations of procera gum and hydroxypropyl methylcellulose (HPMC) and evaluated for their physical properties like weight variation, hardness, friability and content uniformity. Dissolution study was conducted to characterize release mechanism from the matrix system and data were fitted to various kinetic models. The mechanism of drug release from both types of matrix tablets was found to be anomalous type. Results from various evaluations suggested that A. procera gum could be used as drug release retardant in controlled release matrix systems.

Corrosion inhibitors from expired drugs

This paper presents a method of expired or unused drugs valorization as corrosion inhibitors for metals in various media. Cyclic voltammograms were drawn on platinum in order to assess the stability of pharmaceutically active substances from drugs at the metal–corrosive environment interface. Tafel slope method was used to determine corrosion rates of steel in the absence and presence of inhibitors. Expired Carbamazepine and Paracetamol tablets were used to obtain corrosion inhibitors. For the former, the corrosion inhibition of carbon steel in 0.1molL−1 sulfuric acid solution was about 90%, whereas for the latter, the corrosion inhibition efficiency of the same material in the 0.25molL−1 acetic acid–0.25molL−1 sodium acetate buffer solution was about 85%.

<i>In-vitro</i> comparative evaluation of quality control parameters between paracetamol and paracetamol/caffeine tablets available in Bangladesh

Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. The study was conducted to assess the comparative in-vitro quality control parameters through the evaluation of weight variation, hardness, friability, disintegration time and dissolution profile between the commercially available tablet brands of paraceta-mol and paracetamol/caffeine combination in Bangladesh. Tablets of five top level manufacturers those have both of the formulations were evaluated in two groups. Both similarities and dissimilarities were found between the groups. All tablets either paracetamol (1.07 to 2.14%) or paracetamol/caffeine (0.98 to 2.09%) showed acceptable weight variation and friability (below 1%). Formulations were somewhat different in their hardness, disintegration time and dissolution profile. All tablets of paracetamol/caffeine were found harder than paracetamol tablets of the same manufacturer. 1 out of 5 for paracetamol and 3 out of 5 for paracetamol/caffeine tablets exceeded the limit of tablet hardness or crushing strength. The disintegration time in 0.1N HCl of paracetamol tablet brands (24 seconds to 4 minutes 52 seconds) were less than the paracetamol/caffeine (6 minutes 33 seconds to 17 minutes 43 seconds) brands. On the other hand in phosphate buffer, pH 7.4, paracetamol/caffeine tablets dissolved quickly and showed better release profile than tablets containing only paracetamol. It can be concluded that standard quality control parameters always should be maintained not only for paracetamol or its combination but also for all kinds of medicine for getting better drug products.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10282International Current Pharmaceutical Journal 2012, 1(5): 103-109

Highly sensitive sequential injection determination of p-aminophenol in paracetamol formulations with 18-molybdodiphosphate heteropoly anion based on elimination of Schlieren effect

A highly sensitive, precise and automated method using sequential injection analysis to assay quantitatively low levels of the p-aminophenol (PAP) in paracetamol formulations has been developed. A solution containing PAP and paracetamol is injected into an acetate buffer carrier stream and merged on-line with 18-molybdodiphosphate heteropoly complex reagent to form a specific blue derivative that is subsequently detected spectrophotometrically at 820nm. The procedure has been optimized mainly with respect to measurement sensitivity. It is based on the leveling off of the refraction indices of the liquids mixed in the flow system by the careful matching of the refractive index of the reagent solution with that of the carrier and sample solutions. Amount as low as 0.5μmolL−1 of PAP, which corresponds to the 0.001% of PAP in paracetamol tablets, can be reliably determined using the proposed method, which is clearly below the specification limits recommended for PAP determination in paracetamol drug and tablet formulations (50ppm or 0.005% (w/w)). The developed method was successfully applied to the analysis of paracetamol formulations spiked with PAP and determination of PAP content in Rapidol tablets past their expiration date both by proposed SIA and reference HPLC methods.

Evaluation of Sesamum indicum gum as a binder in the formulation of paracetamol granules and tablets

Comparative evaluation of Sesamum indicum gum as a binder in the formulation of paracetamol (PCM) granules and tablets was performed using acacia, gelatin, and Sodium carboxyl methylcellulose (SCMC) as standard binders for comparison. The properties of granules and tablets such as; flow rate, angle of repose, density, weight uniformity, crushing strength, friability, disintegration rate and release profiles, were evaluated. The compact granules had good flow properties. However, binder concentration influenced flow characteristics. SIG gave the highest hardness/friability ratios. It also prolonged disintegration and dissolution time and dissolution rate. Hence, SIG may not be useful as a binder in conventional tablet formulation but may serve as a binder or hydrophilic polymer in sustained release tablet formulation. Key words: Sesamum indicum gum, binder, paracetamol tablets.

An in vitro Study of the Effect of Some Commonly Used Antacids on the Release Profile of Paracetamol and Metronidazole Tablets

This study reports on the effect of magnesium oxide, magnesium trisilicate, aluminium hydroxide and bentonite antacids on the disintegration and dissolution characteristics of commercial paracetamol and metronidazole tablets. The effect of salt on the interaction between the drugs and the antacids was also studied. The disintegration times of the tablets were determined in the different antacid solutions while the effect of antacids on dissolution was studied by adding various amounts of the antacid powders to the dissolution medium. The presence of magnesium trisilicate, magnesium oxide and bentonite delayed disintegration of paracetamol tablets. Generally, the introduction of 7.5% w/w sodium chloride into each of the antacid resulted in a reduction in disintegration time of paracetamol tablets. Combination of the antacids resulted in a greater retardation of dissolution of the paracetamol and metronidazole tablets. The retardation of dissolution of metronidazole from the tablets followed the rank order: bentonite > magnesium trisilicate > magnesium oxide > aluminium hydroxide. The addition of salt to magnesium trisilicate and bentonite dissolution medium decreased T50 and T70 with 7.5% w/w sodium chloride causing a greater reduction than 5.0% w/w. The results suggest that concomitant administration of magnesium oxide, magnessium trisilicate, aluminium hydroxide and bentonite with paracetamol and metronidazole should be discouraged since the bioavailability of these drugs may be compromised. Keywords: Antacids, disintegration and dissolution times, paracetamol, metronidazole East and Central African Journal of Pharmaceutical Sciences Vol. 15 (2012) 10-17

Simultaneous, Stability Indicating Method Development and Validation for Related Compounds of Ibuprofen and Paracetamol Tablets by RP-HPLC Method

A simple, precise, accurate, simultaneous and stability-indicating RPLC method developed with an effective resolution for active pharmaceutical ingredients and marketed drug products. This method effectively separate all the related substances of Ibuprofen and Paracetamol along with impurities. This method is using in the estimation assay of Ibuprofen and paracetamol in drug substance also. The method was developed using RP18 Embedded polar phase column. A mobile phase used in this method was a mixture of acetonitrile and 0.1% v/v orthophosphoric acid in 55:45 v/v ratio. At 230 nm compounds will eluted and monitored. Ibuprofen and Paracetamol was subjected to the stress conditions of acid, base, oxidative, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating ability of the method. The developed method was validated as per USP and International Conference on Harmonization (ICH) guidelines. The current method has proven good linearity and accuracy over the range of all known impurities from LOQ to 150% of the target concentration. The degree of reproducibility as results obtained by deliberate changes in the method parameter and variety of condition has proven the method is robust and rugged.

Evaluation of dibutyrylchitin as new excipient for sustained drug release

Dibutyrylchitin (DBC), a lipophilic chitin diester, has been synthesized from chitin and butyric anhydride with methanesulfonic acid as catalyst. Exhaustive esterification of free alcoholic groups of chitin was assessed by FT-IR and 1H-NMR spectroscopy. High degree of alkyl substitution allowed DBC to acquire an almost completely lipophilic character. Tablets of paracetamol and metformin employing DBC as major excipient, in comparison with starch, microcrystalline cellulose, lactose and polyvinylpyrrolidone, were prepared and rates of drug release were checked by dissolution test assays. DBC released drug at a lower rate than that of the other tested materials. A comparison study of rate release of metformin from DBC tablets and from metformin-hydroxypropyl methylcellulose prolonged release oral formulation available on the market has been also curried out. Under the same conditions and in the presence of the same amount of loaded drug, DBC released 64% of metformin whereas hypromellose-based tablets released 87%.

Investigation of the effects of certain formulation factors on release properties of paracetamol tablets using 23 factorial design

Objective: To study the effects of three formulation variables (PVP, stearic acid and Avicel PH101) on disintegration time and release properties of paracetamol tablets using a 23 factorial experimental design.Methodology: Three formulation variables; Polyvinyl pyrrolidone (factor A), Stearic acid (factor B) and Avicel PH 101 (factor C) were used at two concentrations levels in paracetamol tablet formulation. The estimated effects of increasing the factors from a low to a high level were testedfor significance by analysis of variance. The release properties of the tablets- measured by the disintegration and the dissolution times were used as assessment parameters.Results: Changing the concentration of factor A from” low” to “high” led to an increase in the disintegration time of the tablets. The disintegration of the tablets is not affected by factor B or C. All investigated factors in 23 factorial design had a significant effect on dissolution time. Theranking of the factors was C > B > A.Conclusion: The results suggest that factorial design could be useful to produce tablets with particular drug release profiles and there was a considerable interaction between the variables employed on the tablet dissolution rate.

The effect of Yoyo bitters on the pharmacokinetics of single oral dose paracetamol tablet in human volunteers

Paracetamol (Tylenol, acetaminophen) and Yoyo bitters (a liquid oral herbal preparation) are known prescriptive drugs and widely available to ¡§patients¡¨. They are taken individually or as combination therapy atslightest signs/symptoms of fever in Nigeria. The pharmacokinetics of oral single dose paracetamol (1000 mg tablet), was evaluated in eight healthy male volunteers. Experiment was carried out in three phases. In the 1stphase, only oral paracetamol tablet was administered to subjects, while in the 2nd phase, subjects were administered paracetamol at the same time with Yoyo bitters and in the 3rd phase, (delayed protocol) the subjects were administered paracetamol after taking Yoyo bitters for 3 days. Blood samples were collected and analyzed for paracetamol using  spectrophotometric method. The values obtained for the pharmacokineticsparameters when paracetamol was administered alone falls within previously reported values. Yoyo bitters did not statistically (P>0.05) affect the pharmacokinetics of paracetamol when administered concurrently withYoyo bitters. However when administered after three days of Yoyo bitters administration, there was statistically significant (P<0.05) increase in AUC0-¡Û and t1/2£] while there was significant (P<0.05) decrease inK£] ƒnand Cl/F.

Microcrystalline cellulose powder tableting via networked cellulose-based gel material

Networked cellulosic (NC) gel material was prepared via 70% sulfuric acid dissolution and hydrolysis of microcrystalline cellulose (MCC) followed by regeneration in cold ethanol. The material was utilized as a multifunctional excipient for drug tablets production. Placebo tablets were prepared via slip-casting of simple formulas containing different concentrations of NC. The hardness of the prepared tablets was measured using tablet hardness tester and increased over a wide range and up to 420N. It was noticed that the hardness is mainly dependent on NC material concentration in the formulation. Furthermore, high tablet hardness was observed using tablet friability tester. Paracetamol tablets of 30mg label claim were prepared in a similar way. Despite their high hardness, the tablets showed a full drug release capability over time and up to 24h. The release time was also influenced by the NC concentration. Content uniformity and mass variation testing of these tablets have confirmed the product homogeneity and proved the efficiency of slip-casting as a tablets production technique.

Effect of the mode of incorporation on the disintegrant properties of acid modified water and white yam starches

Acid modified starches obtained from two species of yam tubers namely white yam –Dioscorearotundata L. and water yam –D. alata L. DIAL2 have been investigated as intra- and extra-granular disintegrants in paracetamol tablet formulations. The native starches were modified by acid hydrolysis and employed as disintegrant at concentrations of 5 and 10% w/w and their disintegrant properties compared with those of corn starch BP. The tensile strength and drug release properties of the tablets, assessed using the disintegration and dissolution (t50 and t80 – time required for 50% and 80% of paracetamol to be released) times, were evaluated. The results showed that the tensile strength and the disintegration and dissolution times of the tablets decreased with increase in the concentration of the starch disintegrants. The acid modified yam starches showed better disintegrant efficiency than corn starch in the tablet formulations. Acid modification appeared to improve the disintegrant efficiency of the yam starches. Furthermore, tablets containing starches incorporated extragranularly showed faster disintegration but lower tensile strength than those containing starches incorporated intragranularly. This emphasizes the importance of the mode of incorporation of starch disintegrant.

Post–market In vitro Equivalency Evaluation of Paracetamol Tablets in Kedah, Malaysia

Six brands of paracetamol (acetaminophen) 500 mg tablets have been evaluated using specific quality control tests for uniformity of weight, hardness, friability, content, disintegration and dissolution with the aim to assess its bioequivalence. The results obtained have been discussed in details using monographs in United States Pharmacopeia and British Pharmacopoeia. In conclusion, despite some apparent minor differences in tablet hardness and disintegration time profiles, the dissolution characteristics of various paracetamol tablets appears to be similar and not significantly different from various manufacturers.