Paracetamol Tablets Research Articles

Characterization and antioxidant potential of Coccinia indica fruit mucilage: Evaluation of its binding properties

Systemic investigation of natural polysaccharides and their derivatives can lead to interesting discoveries in the fields of therapeutic and industrial research; allowing them to compete with synthetic products. The aim of the study was to isolate and characterize mucilage (dietary fiber) from Coccinia indica to assess its suitability as excipient and to evaluate its antioxidant potential. The mucilage so isolated was characterized for various physicochemical properties as swelling index, ash value, moisture content, microbial load, total polysaccharide, uronic acid content and rheological properties. Paracetamol tablet containing mucilage at concentration of 2.5% w/w, 5% w/w, 7.5% w/w, 10% w/w as binder was prepared by wet granulation and compared with standard binder acacia. The prepared tablets were evaluated for various pre-compression and post-compression parameters. The drug excipient interaction was characterized by DSC and antioxidant potential by DPPH. Formulation at concentration of 5% w/w exhibited good flow properties, compressibility and drug release. Furthermore, it exhibited strong antioxidant activity by scavenging DPPH. The crude mucilage (dietary fiber) from C. indica is an excellent source towards its development as excipient to nutraceutical/pharamaceutical and functional food in prevention of various disease.

PHYSICOCHEMICAL CHARACTERIZATION OF ACID MODIFIED DIOSCOREA STARCH AND ITS EVALUATION AS DIRECTLY COMPRESSIBLE EXCIPIENT IN TABLET FORMULATION

D. abyssinica was partially hydrolyzed in 6% HCl solution at room temperature for different lengths of time, (2, 4, 8, 16, and 32 days), dried using oven- and spray- drying techniques and subsequently investigated as directly compressible excipient in paracetamol tablet formulations. Native dioscorea starch (NDS) and oven dried acid modified dioscorea starch (AMDS) exhibited poor flow characteristics, whereas spray dried AMDS was found to be free flowing powder with 21.37 ± 1.39° angle of repose and 13.24 ± 0.76 g/sec flow rate. Both swelling power and percent solubility of the starches were found to increase with increase in temperature; AMDS showed higher percent solubility of 68.53%. Lubricant sensitivity and dilution potential of spray dried NDS and spray dried AMDS were investigated by incorporating magnesium stearate and paracetamol, respectively. In tablet formulations, spray dried AMDS and Starch 1500® tablets were produced with acceptable tablet characteristics up to 1% and 0.5% magnesium stearate concentrations, respectively. The spray dried AMDS was able to accommodate up to 40% paracetamol with acceptable criteria. Thus, it can be concluded that AMDS can be used as an alternative directly compressible excipient in tablet formulations. Keywords: Dioscorea starch, acid modification, spray drying, directly compressible excipient.

Quality analysis of different marketed brands of paracetamol available in Bangladesh

Paracetamol is a widely used analgesic and antipyretic drug worldwide. The present study was conducted to analyze the quality of seven marketed brands of paracetamol tablet formulation manufactured by different multinational and national companies. The tablet formulations of different brands were tested for various parameters like weight variation, hardness, friability, disintegration time and dissolution profile using standard techniques to evaluate their quality. The values were compared with the standards. Weight variation value requirement was complied by all brands. All studied samples except two local products complied with the standard specification for tablet hardness. All brands showed impressive friability values and products of multinational companies comparatively exhibited the highest values. Disintegration time for all brands was within 15 minutes also complying the USP (United State of Pharmacopeia) recommendation. Moreover, the release rate of different brands of paracetamol was satisfactory within 45 minutes and ranged from 79.82% to 103.53%. Therefore, it can be concluded that almost all the brands of paracetamol that are available in Bangladesh meet the USP specification for quality control analysis.Kar et al., International Current Pharmaceutical Journal, August 2015, 4(9): 432-435

Drug utilization pattern of NSAIDs assessed with the anatomical therapeutic chemical classification/defined daily dose system in an orthopedic department

To study the drug utilization pattern of NSAIDs using the Anatomical Therapeutic Chemical classification/Defined Daily Dose (ATC/DDD) system in patients admitted to the orthopedic department of a tertiary-care teaching hospital. A cross-sectional prospective observational study was carried out in 200 patients from March to August 2014. Demographic information, disease related details, drug history and adverse drug reactions (ADRs) were recorded by personal interview and from case files daily for drug utilization analysis. The majority of patients were aged 18–30 years (30 %), most were male (80 %) and the most common orthopaedic condition causing hospitalization was fracture/dislocation (77 %). The most commonly prescribed drug group was analgesics, with NSAIDs being the most commonly prescribed type of analgesic (97 %). The majority of prescribed drugs were from the World Health Organization (WHO) Essential Medicine List (92 %) and Indian national essential drug list (100 %). Polypharmacy and high polypharmacy was reported in 71 and 14.5 % of patients respectively. No fixed-dose combinations of analgesics were used. Oral tablet diclofenac (M01AB05) 50 mg was the most frequently prescribed analgesic (97 % of patients; 840.5 DDD), followed by intravenous injection tramadol (N02AX02) in 56 % (189.3 DDD), intramuscular injection diclofenac (M01AB05) 75 mg in 55 % (87 DDD) and oral tablet paracetamol (N02BE01) 500 mg in 38.5 % (58.3 DDD) of patients. ADRs (mainly gastritis despite concomitant use of histamine H2 blockers) were reported in 4 % of patients; all ADRs were of ‘possible’ category according to the WHO–Uppsala Monitoring Centre causality assessment method. Fracture-dislocation and arthritis were the most common causes for hospitalization in the orthopedic department. Selection of analgesics and their dosage regimen complied with the WHO guidelines of pain management.

Nimesulide induced leukocytoclastic vasculitis and hepatitis: a case report.

BackgroundNimesulide is a non-steroidal anti-inflammatory drug with antipyretic and analgesic properties, which is still used in many countries despite its known hepatotoxicity. Along with hepatotoxicity it has also been associated with several other Adverse Drug Reactions (ADRs) including leukocytoclastic vasculitis (LCV).Case descriptionA 38 year-old female presented with history of acute onset fever for which she took tablet nimesulide and paracetamol combination (100 mg Nimesulide + 500 mg paracetamol tablet), 1 tab three times daily for 4 days, following which she developed rash all over the body. She also had clinical and biochemical evidence of acute hepatitis. Histopathological examination of the skin rash documented the presence of LCV. She was managed symptomatically with anti-inflammatory and supportive therapy and was not further exposed to nimesulide.Discussion and evaluationOur case demonstrates occurrence of acute hepatitis and LCV associated with nimesulide intake. The case meets the defining criteria for the diagnosis of LCV preceded by history of nimesulide intake. There was also clinical and biochemical evidence of hepato-cellular damage which supports the concurrent development of hepatitis along with the development of LCV following nimesulide use. To the best of our knowledge there is no previous published report of LCV and hepatitis occurring concurrently in the same patient following nimesulide intake. Nimesulide should be added to the list of agents associated with these serious adverse drug reactions.ConclusionsNimesulide has been a contentious drug over many years. Under such evidence of serious ADRs the scientific community should consider ensuring strict pharmacovigilance with respect to its use especially in the developing countries where such monitoring systems are inadequate.

Effect of thermal and chemical modifications on the mechanical and release properties of paracetamol tablet formulations containing corn, cassava and sweet potato starches as filler-binders

ObjectiveTo investigate the effects of acetylation and pregelatinization of cassava and sweet potato starches on the mechanical and release properties of directly compressed paracetamol tablet formulations in comparison with official corn starch. MethodsThe native starches were modified by acetylation and pregelatinization. The tablets were assessed using friability (Fr), crushing strength (Cs), disintegration time (Dt) and dissolution parameters. ResultsStarch acetylation produced paracetamol tablets that were stronger and had the best balance of mechanical and disintegration properties, while pregelatinization produced tablets that were more friable but had a better overall strength in relation to disintegration than formulations made from natural starches. Correlations mainly existed between Dt and the dissolution parameters t80, t2 and k1 in the formulations. ConclusionsModification of the experimental starches improved the mechanical and release properties of directly compressed paracetamol tablet formulations. Thus, they can be developed for use as pharmaceutical excipients in specific formulations.

Flavonoids mixture (diosmin, troxerutin, hesperidin) in the treatment of acute hemorrhoidal disease: a prospective, randomized, triple-blind, controlled trial.

The role of a mixture of phlebotonics in the treatment of acute hemorrhoid crisis is investigated to test their efficacy. One hundred and thirty-four consecutive patients with an acute hemorrhoidal crisis recruited in five colorectal units entered the study. Sixty-six of them were randomized to receive a mixture of diosmin, troxerutin and hesperidin (group A), and 68 a placebo (group B). The main symptoms, the use of oral painkillers and the Bristol scale score were recorded at each scheduled visit and compared using both Student's t test for independent samples and the ANOVA models for repeated measures. The presence of edema, prolapse and thrombosis were also recorded and compared using the Chi-square test. Furthermore, the trend of proportions during the time of the evaluations was assessed by the Chi-square test for linear trend. Pain, bleeding and the proportion of patients who reported persistence of edema and thrombosis decreased significantly after 12 days of treatment in group A. After 6 days, the number of paracetamol tablets taken by patients in group A was significantly lower than the amount of flavonoid mixture. The use of a mixture of diosmin, troxerutin and hesperidin is a safe and effective mean of managing symptoms of acute hemorrhoidal disease. Furthermore, in patients receiving treatment, there was faster control and lower persistence of edema and thrombosis.

Batch-specific discrimination using nuclear quadrupole resonance spectroscopy.

In this paper, we report on the identification of batches of analgesic paracetamol (acetaminophen) tablets using nitrogen-14 nuclear quadrupole resonance spectroscopy ((14)N NQR). The high sensitivity of NQR to the electron charge distribution surrounding the quadrupolar nucleus enables the unique characterization of the crystal structure of the material. Two hypothesis were tested on batches of the same brand: the within the same batch variability and the difference between batches that varied in terms of their batch number and expiry date. The multivariate analysis of variance (MANOVA) did not provide any within-batches variations, indicating the natural deviation of a medicine manufactured under the same conditions. Alternatively, the statistical analysis revealed a significant discrimination between the different batches of paracetamol tablets. Therefore, the NQR signal is an indicator of factors that influence the physical and chemical integrity of the material. Those factors might be the aging of the medicine, the manufacturing, or storage conditions. The results of this study illustrate the potential of NQR as promising technique in applications such as detection and authentication of counterfeit medicines.

Polyelectrolyte functionalized gold nanoparticles-reduced graphene oxide nanohybrid for electrochemical determination of aminophenol isomers

A green chemical method for preparation of gold nanoparticles-reduced graphene oxide nanocomposite is described. This can be readily accomplished through a two-step chemical reduction scheme by using poly(diallyldimethylammonium chloride), a cationic polyelectrolyte as a common reducer. Polyelectrolyte here also serves to stabilize gold nanoparticles and is beneficial to electrical communication, leading to the formation of well-characteristic nanohybrid. The prepared nanomaterial showed remarkable electrocatalytic ability as a result of the rational conjunction of graphene and gold nanoparticles, which was demonstrated by direct electrochemical determination of three aminophenol isomers on a modified glassy carbon electrode. Effective peak separation of three isomers was achieved due to the favorable electron-transfer network perfectly assembled on the electrode surface, thus enabling the simultaneous assay of multiple components featuring analogous chemical structure without chromatographic separation. The modified electrode was further used to detect para-aminophenol in paracetamol tablets. The present method is simple, eco-friendly and holds potential for electroanalytical and biosensing applications.

Validation and Optimization of a Simple RP-HPLC Method for the Determination of Paracetamol in Human Serum and its Application in a Pharmacokinetic Study with Healthy Bangladeshi Male Volunteers

Acetaminophen (paracetamol) is an analgesic and antipyretic agent with minimum anti-inflammatory properties. In the present study a simple, fast, accurate, precise and reproducible RP-HPLC method has been developed and validated for the quantification of paracetamol in human serum samples using theophylline as internal standard. Protein precipitation with perchloric acid was employed in the extraction of paracetamol and theophylline from biological matrix. The chromatographic separation was accomplished on Phenomenex C18 column with a mobile phase comprising of 0.05 mM sodium sulfate buffer (pH 2.2 ± 0.02 adjusted with phosphoric acid) and acetonitrile at a ratio of 93:7 at a flow rate of 1.0 ml/min. The chromatogram was monitored by UV detection at a wavelength of 254 nm. The method was validated over a linear concentration range of 2-100 ?g/ml and limit of quantification (LOQ) was 1.61 ?g/ml with a correlation coefficient (r2) 0.997. The intra-day and inter-day precision expressed as relative standard deviation were found to be 0.49 - 2.68% and 0.36 - 3.44%, respectively. The average recovery of paracetamol from serum ranged from 99.0 - 106.4%. The method was successfully applied to a pharmacokinetic study after oral administration of immediate release paracetamol tablet (1000 mg) in four healthy Bangladeshi volunteers. The mean Cmax was found to be 11.03 ± 3.21 ?g/ml, which occurred at Tmax of 0.88 ± 0.14 hr. The half life, AUC0-8 and AUC0-? values were found to be 3.09 ± 0.71 hr, 31.06 ± 6.57 hr-?g/ml and 37.92 ± 9.51 hr- ?g/ml, respectively. DOI: http://dx.doi.org/10.3329/dujps.v13i2.21889 Dhaka Univ. J. Pharm. Sci. 13(2): 125-131, 2014 (December)

The safety and efficacy of an enzyme combination in managing knee osteoarthritis pain in adults: a randomized, double-blind, placebo-controlled trial.

This randomized, double-blind, placebo-controlled, and comparator-controlled trial evaluated the safety and efficacy of an enzyme combination, as Wobenzym, in adults with moderate-to-severe osteoarthritis (OA) of the knee. Adults (n = 150) received Wobenzym, diclofenac (a nonsteroidal anti-inflammatory drug, NSAID), or placebo for 12 weeks. Improvement in pain scores (Lequesne Functional Index) did not differ between subjects treated with Wobenzym or diclofenac, and both treatment groups improved compared to placebo (P < 0.05). Reduction in total WOMAC scores (secondary outcome measure) did not differ between Wobenzym and diclofenac, although only diclofenac emerged as different from placebo (P < 0.05). The median number of rescue medication (paracetamol) tablets consumed was less in the Wobenzym group compared to placebo (P < 0.05), while there was no difference between diclofenac and placebo. Adverse events were similar in frequency in Wobenzym and placebo groups (7.2% and 9.1% of subjects, resp.) and higher in diclofenac group (15.6%). Wobenzym is comparable to the NSAID diclofenac in relieving pain and increasing function in adults with moderate-to-severe painful knee OA and reduces reliance on analgesic medication. Wobenzym is associated with fewer adverse events and, therefore, may be appropriate for long-term use.

Simultaneous determination of epinephrine, paracetamol, and folic acid using transition metal ion-exchanged polyaniline–zeolite organic–inorganic hybrid materials

Transition metal ion-exchanged polyaniline–zeolite (M2+-PANI-Nano-ZSM-5, where M2+=Cu2+, Ni2+, Co2+, Fe2+, and Mn2+) organic-inorganic hybrid materials were synthesized and characterized by the complementary combination of X-ray diffraction, N2-adsorption, scanning electron microscopy, FT-IR and thermo gravimetric techniques. Electrochemical sensors based on M2+-PANI-Nano-ZSM-5 was developed for the simultaneous determination of epinephrine, paracetamol, and folic acid. Among the materials investigated in this study, Cu2+-PANI-Nano-ZSM-5 modified glassy carbon electrode exhibited the highest electro-catalytic activity with excellent stability, sensitivity, and selectivity. Under the optimum conditions, a wide linear range was obtained from 10nM–600μM for epinephrine, 15nM–800μM for paracetamol, and 13nM–700μM for folic acid. The detection limit was found to be 4, 8, and 5nM for epinephrine, paracetamol, and folic acid, respectively. The analytical performance of the developed sensor was demonstrated in the determination of epinephrine, paracetamol, and folic acid in the commercial pharmaceutical preparations (epinephrine injection, paracetamol, and folic acid tablets) with satisfactory recovery. The proposed methodology provides promising application in drug analysis.

Studi Pengaruh Bahan Tambahan pada Pola Puncak Kromatogram Tablet Parasetamol dengan Tlc-spektrofotodensitometri untuk Drug Profiling

The study of chromatogram peak pattern by influence of excipient in paracetamol tablet with TLC- Spectrophotodensitometry method for drug profiling has been done. Sample (6 kind of paracetamol tabletsfrom different factory) and reference compounds were analyzed with TB (cyclohexane : toluene:diethylamine = 75:15:10) and TAEA (toluene : acetone : ethanol: ammonia = 45:45:7:3) as mobile phase andAl-TLC Si 60 G F254 as stationary phase.The initial step was non analyte peak reduction on Al-TLC plate with washing method, drying time and temperature variation. Sample was extracted with 1 ml chloroform and Na2CO3 buffer pH 10 and spotted onAL-TLC plate. First, sample extract from same factory was spotted on one plate, continued by sample extractfrom 6 different factories on one plate which is replicated five fold on each plate that different. Plate was eluted and scanned at 210 nm. Chromatogram was analyzed by cosine and cluster function. C95 value thatwas calculated from sample was used as a parameter to determine the influence of excipient towardchromatogram peak pattern.The result of this research showed that each tablet from same factory gave C95 value near 100 if calculated with cosine function (96 - 98,7 for TB and 78 - 83 for TAEA), whereas if all tablets from 6different factories was used, the excipient from each tablet will give C95 value alteration (63 for TB and 68 for TAEA). Cluster analysis will divide sample into 3 different groups for TB and 1 group for TAEA.

DRUG DEVELOPMENT BY MOLECULAR HYBRIDIZATION: A MEDICINAL CHEMISTRY PRACTICE CLASS USING PARACETAMOL AND SULFADIAZINE TABLETS AND THE VIRTUAL TOOLSciFinder®

Medicinal Chemistry is a multidisciplinary discipline and the discovery of new bioactive molecules is one of its objectives. Molecular Hybridization (MH) is a strategy of rational design of new prototypes, where the lead compound is produced through an adequate fusion of pharmacophoric sub-unities. Undergraduate laboratory experiments for Medicinal Chemistry education with a focus on MH are scarce. Therefore, the present paper describes a practice class for some undergraduate courses (Pharmacy, Chemistry and/or Chemical Engineering) involving drug development and MH that can be performed at low cost. In this work, alternative materials such as paracetamol and sulfadiazine tablets were used to engage student's attention and to contextualize important concepts of MH. The experiment describes the synthesis of a new compound involving the azo coupling between an aromatic amine (sulfadiazine) and a phenol (paracetamol) to show undergraduate students a practical example of MH. In this case, SciFinder® - a search website of the American Chemical Society - was also demonstrated and utilized as a search tool in the proposed experimental class.

Evaluation of metrological characteristics of spectrophotometric quantitative determination of paracetamol in tablets by specific absorbance

The validation characteristics of the spectrophotometric quantitative determination of paracetamol in tablets by specific absorbance according to the British Pharmacopoeia (BPh) have been evaluated. The results of paracetamol content of 83.59% and 84.39% in terms of the average mass of one tablet do not meet the permissible limits B ±5.0%. The peculiarities of the sample preparation method for quantitative determination of the active pharmaceutical ingredient in tablets has been discussed, and comparative analysis of “Dissolution” and “Assay” tests for paracetamol tablets according to the BPh has been conducted. We have suggested to make such changes at the stage of the sample preparation as “… place the flask in an ultrasonic bath for 30 min…” instead of “…shake for 15 minutes…”. The acceptance criteria of the assay method for paracetamol tablets have been calculated for permissible limits of ±5.0%, ±7.5%, ±10.0%. The results of the convergence and linearity research of the method meet requirements for the permissible limits of ±5.0%. The results of the intermediate precision re-search of the method meet requirements for the permissible limits of ±7.5%. The results of the accuracy research of the method meet requirements for the permissible limits of ±10.0%. Taking into account the technical capabilities of the Ukrainian producers and a diverse list of excipients used in the manufacture of the drug, the spectrophotometric quantitative determination of paracetamol tablets by specific absorbance is recommended to use with the permissible limits of ±10.0%. The prognosis of the total uncertainty of the analysis results is consistent with requirements to the maximum permissible uncertainty of the analysis Δ10.0%As = 2.6 ≤ max Δ10.0%As= 3.2% and with results of the 3rd round of the Professional Testing Programme (PTP) of “Pharma-test” laboratories in the system of the State Inspection for Medication Quality Control of the Ministry of Public Health of Ukraine.

A Tape Method for Fast Characterization and Identification of Active Pharmaceutical Ingredients in the 2-18 THz Spectral Range

In order to find counterfeit drugs quickly and reliably, we have developed ‘tape method’ a transmission spectroscopic terahertz (THz) measurement technique and compared it with a standard attenuated total reflection (ATR) THz spectroscopic measurement. We used well-known training samples, which include commercial paracetamol and aspirin tablets to check the validity of these two measurement techniques. In this study, the spectral features of some active pharmaceutical ingredients (APIs), such as aspirin and paracetamol are characterized for identification purpose. This work covers a wide THz spectral range namely, 2-18 THz. This proposed simple but novel technique, the tape method, was used for characterizing API and identifying their presence in their dosage forms. By comparing the spectra of the APIs to their dosage forms (powder samples), all distinct fingerprints present in the APIs are also present in their respective dosage forms. The positions of the spectral features obtained with the ATR techniques were akin to that obtained from the tape method. The ATR and the tape method therefore, complement each other. The presence of distinct fingerprints in this spectral range has highlighted the possibility of developing fast THz sensors for the screening of pharmaceuticals. It is worth noting that, the ATR method is applicable to flat faced tablets whereas the tape method is suitable for powders in general (e.g. curved surface tablets that require milling before measurement). Finally, we have demonstrated that ATR techniques can be used to screen counterfeit antimalarial tablets.

Analysis of activities of some starch disintegrants in paracetamol tablets by application of a factorial experimental design

The effects of the nature of disintegrant (N), its concentration(C) and its type (T) on the disintegrant properties - crushing strength (Cs), friability (Fr) and disintegration time (Dt) - of paracetamol tablets formulated with starch disintegrants from white and yellow trifoliate yam varieties (Dioscorea dumetorum Pax) and rice (Oryza sativa, Linn) were studied comparatively with those containing official corn starch by the application of statistical principles based on a 23 experimental design. Generally, for all the starch disintegrants, the ranking for the individual effects on Cs, Fr and Dt were N>C>T, N>C>T and C>F>T, respectively. The general ranking for the interactions would appear to be N-C > C-T > N-T. From these, it may be inferred that the concentration of disintegrant, C which is apparently involved in the two largest groups of interaction is generally the most important in influencing the effects of the variables on the disintegration properties of the various starches since it would influence the effects of the two other variables considerably. These findings can be useful in manipulating the variables to obtain desired disintegration properties for formulated paracetamol tablets.

Preliminary investigation of mechanical properties of paracetamol tablets formulated with microcrystalline cellulose binder derived from Saccharum officinarum, L.

Microcrystalline cellulose (MCC) is a multifunctional excipient in drug formulation. However, the dependent of most developing countries on importation of this excipient invariably increases the cost of drug production. Thus, this work preliminarily assessed the suitability of the MCC derived from partially processed stem of Saccharum officinarum, L. (DMCC) comparatively with commercial MCC (Avicel® PH 101) incorporated as binders in a paracetamol tablet formulation. The excipients were assessed based on their physicochemical and flow properties. The formulated tablets, compressed at three different loads – 10, 15 and 20 KgF – were evaluated for weight uniformity, crushing strength and friability. The flow indices showed that both DMCC and Avicel® PH 101 have comparably good flowability. Tablets containing DMCC showed excellent weight uniformity, crushing strength and friability and all conformed to official monograph. There were no significant difference between the parameters determined for the two binders (p 0.05). The results obtained are suggestive of the fact that the use of DMCC as binder compared well with the commercial MCC and may thus be developed as a potential substitute in some tablet formulations.

Interchangeability Study of Multisource Paracetamol 500mg Tablets, Produced in Mongolia.

To define interchangeability of locally produced Paracetamol (Acetaminophen INN), 500mg tablets. For this purpose Paracetamol 500mg tablets produced by 7 local manufacturers were tested. As a comparator product was used Panadol 500mg, produced by GlaxoSmithKline. Bioequivalence testing was done according to the WHO guideline, Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability, WHO Technical Report Series, №.937, 2006. Based on Biopharmaceutics Classification System Paracetamol tablets bioequilvalency testing was done in vitro through determination of dissolution. In each media of pH 1.2, 4.5 and 6.8 were tested 12 unit samples. All samples were dissolved in three media in not less than 85% of the labelled amount of the paracetamol in 15 minutes. According to the questionnaire, all manufacturers producing Paracetamol tablets answered that the formulation of dosage form was considered the attribute of active pharmaceutical ingredient and excipients and used machinery’s specification. As criteria for choosing the formulation, manufacturers were used pharmacopoeial monograph, stability study data and dissolution results. Mongolian manufacturer’s Paracetamol formulations not contain excipients such as sodium bicarbonate, which is fastening the drug absorption. Three manufacturers use Povidone as a binder, same like comparator product. Most formulations contain Talc and Magnesium stearate as a lubricant mix, when comparator contains Stearic acid and Talc. All formulations contain starch and cellulose, their derivates. Paracetamol 500mg tablets produced by all 7 local manufacturers: LM1, LM2, LM3, LM4, LM5, LM6 and LM7 have dissolution more than 85% in 15 minutes in each of three media. Therefore the dissolution profile comparison with an f2 test is unnecessary [4]. Samples: LM1, LM2, LM3, LM4, LM5, LM6 and LM7 are bioequivalent and could be interchangeable with comparator pharmaceutical product.

Cytological and Histological Effect of Paracetamol on the Testis and Liver in Albino Mice Mus musculus

The purpose of this study is to evaluate the acute toxicity effects of pure paracetamol tablets&#x0D; on laboratory mice. In this study Mus musculus mice (6-8) weeks old were used. The toxicity effects&#x0D; were evaluated on fifteen mice, in which they were divided equally into three groups, each one&#x0D; consists of five individual mice. The first group was labeled as a vehicle group and received 5mL/kg&#x0D; DW. The second and third groups were labeled as experimental groups which received 2 g/kg and 5&#x0D; g/kg of paracetamol respectively. After fifteen days the animals were examined for toxicity signs and&#x0D; then the liver and testis were processed for histological examinations. Furthermore, the sperm&#x0D; abnormalities were recorded. The results of this study demonstrated that the low dose did not show&#x0D; any morphological changes while some changes such as shivering, nausea and mortality were&#x0D; manifested after administration of high dose of paracetamol. Many histological changes have been&#x0D; observed after high dose treatment of paracetamol, the frequencies of abnormal sperm were&#x0D; increased as well. Therefore, Paracetamol, which is believed to be a strong pain killer for the&#x0D; hangover headache may damage liver and testis when consumes beyond the recommended dose.