Paracetamol Tablets Research Articles

Evaluation of tablet disintegrant properties of microcrystalline cellulose obtained from cassava fermentation waste

This study was aimed at exploring the application of microcrystalline cellulose from cassava fermentation waste as a disintegrant in the formulation of paracetamol tablets for immediate release. Alkali delignification of the dried cassava fermentation fibres, followed by bleaching and acid depolymerisation was employed in the extraction of α-cellulose and conversion to microcrystalline cellulose (MCC). The MCC obtained was evaluated for some of its physicochemical properties. Thereafter, a comparative evaluation of paracetamol granules and tablets formulated using the MCC and Avicel ® PH 101 as disintegrants was undertaken. Drug-excipient interaction was also investigated using fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC). Results showed a 48% yield of α-cellulose from the waste material. The MCC powder was off-white in colour, insoluble in water and gritty in texture. It showed negative reaction to the presence of starch, sugar and lignin but positive to cellulose. It exhibited a moisture content and swelling capacity of 2.1 and 63.3%, respectively. The paracetamol granules formulated showed good flowability with angles of repose ≤ 31 °, Hausner’s ratios of 1.07 - 1.18 and Carr’s indices of 6.58 - 16.00%. The formulated tablets showed good hardness (> 7 kp) and friability values (≤ 0.7%). Two batches of tablets containing 7.5 or 10% (w/w) of the MCC and three batches of tablets containing Avicel® (5, 7.5 and 10% (w/w) disintegrated within 15 min. The tablets containing 5 - 10% (w/w) of the MCC or Avicel® passed the dissolution test for tablets which specifies that at least 70% of the drug should be in solution after 30 min. FTIR and DSC analyses revealed no interaction between the excipients and paracetamol. MCC from cassava fermentation waste may serve as an alternative substance to explore as a pharmaceutical excipient in solid dosage form even though its tableting parameters are not as good as those of Avicel® PH 101. Keywords: cassava, microcrystalline cellulose, disintegrant, paracetamol granules, tablets

The effect of Kinesio taping application for acute non-specific low back pain: a randomized controlled clinical trial

Objective: To investigate the effect of Kinesio taping application in acute non-specific low back pain. Design: A randomized controlled clinical trial. Setting: Physical Medicine and Rehabilitation Clinic. Participants: A total of 109 patients with acute low back pain were randomized into either Kinesio taping (n = 54) or control (n = 55) groups. Intervention: The intervention group was treated with information and reassurance plus Kinesio taping, while the control group received merely information and reassurance. All participants were allowed to use as-needed doses of paracetamol. Kinesio tape was applied to the most painful area of the low back for a total of 12 days. Main outcome measures: Worst pain and disability were assessed at baseline, after the 12-day intervention, and at four weeks follow-up. During the first 12 days, participants filled in a pain diary consisting of a numeric rating scale and recorded the number of paracetamol tablets consumed daily. Disability was assessed with the Oswestry Disability Index. Results: After 12 days of intervention, pain intensity and the Oswestry Disability Index improved significantly in both groups; the improvements were significantly superior in the Kinesio taping group (p = 0.003, p = 0.011). The Kinesio taping group reached pain control earlier (sixth day vs. 12th day) and consumed less paracetamol. At the fourth week, although pain intensity was significantly more reduced in the Kinesio taping group (p = 0.015), there were no differences with regard to disability. Conclusions: Kinesio taping provided significant improvements in pain and disability; thus, it can be used as a complementary method in acute non-specific low back pain.

Comparison of environmental sustainability of pharmaceutical packaging

Pharmaceutical companies are increasingly imparting a lot of importance on becoming more sustainable by developing medicines that are having same medicinal value but with reduced environmental impact. Type of packaging of tablets affects the emission generated during packaging of medicines. Selection of an appropriate packaging of medicine also influences the emission added to the environment. This paper aims at the comparison of environmental impacts of two different types of packaging of tablets viz., PVC blister and aluminium blister packaging. Life cycle assessment (LCA) methodology is used for this comparison. The study includes stages from Cradle to Gate that is, extraction till the packaging processes focused mainly on manufacturing. The functional unit is taken as material required for packing 1 lakh (100,000), 500 mg of paracetamol tablets. Primary data is provided by a pharmaceutical formulation industry and secondary data is obtained from a commercial LCA database available in GaBi and from literature. LCA software GaBi 7.0 is used to carry out the life cycle assessment of both kinds of packaging. Life cycle impact assessment (LCIA) method, CML 2001, is used in this study. The study indicates that the PVC blister packaging performs better compared to the aluminium blister packaging in most of the impact categories considered. It is observed that the process of manufacturing of aluminium foils is a significant contributor to the overall environmental impact of aluminium blister packaging.

Studies of the Effect of Storage Conditions on Some Pharmaceutical Parameters of Powders and Tablets

This study evaluates the effect of storage conditions on some pharmaceutical parameters of powders (paracetamol, corn starch, tragacanth and polyvinyl pyrrolidone) and tablets (paracetamol, metronidazole and vitamin C). For powdered samples, angle of repose, bulk and tapped densities were determined while the tablets were evaluated for hardness, friability and disintegration before and after exposure to various humidity conditions, radiations from telecommunication mast and sunlight at intervals of 24 hrs & 1, 2, 4 and 8 weeks. The results showed a decrease in the angle of repose for paracetamol, corn starch, polyvinyl pyrollidone and tragacanth powders on exposure to sunlight. There was no significant (p>0.05) change in the tapped and bulk densities under the different storage conditions over the storage period. No organoleptic changes were observed for any of the samples stored under the environmental conditions over the two-month period. All the tablets stored over the two- month period conformed to the official BP standard for weight uniformity. Paracetamol tablets exposed to 93% relative humidity (RH) showed significantly lower reduction (P<0.05) in hardness compared to the other storage conditions. On prolonged exposure of paracetamol and metronidazole tablets to radiation from telecommunication mast, there was a reduction in tablet hardness and the tablets became friable. The observations of the present study reconfirm the role of storage conditions in ensuring the physical stability of pharmaceutical powders and tablets.\Dhaka Univ. J. Pharm. Sci. 14(2): 147-151, 2015 (December)

Chrysophyllum albidum mucilage as a binding agent in paracetamol tablet formulations

Chrysophyllum mucilage obtained from the fruit of Chrysophyllum albidum (Family Sapotaceae) has been characterised and evaluated as a binding agent in comparison with methylcellulose in paracetamol tablet formulations. Chrysophyllum mucilage was characterised using elemental and proximate analyses as well as material properties. The Heckel and Kawakita plots were used to assess the compressional properties and the tablet properties were evaluated using tensile strength, friability, disintegration and dissolution times. The results showed the presence of calcium, magnesium, potassium, sodium, manganese, iron, copper, zinc and absence of heavy metals from the mucilage. The mucilage exhibited excellent flow and swelling properties, but poor water solubility. The viscosity of chrysophyllum mucilage increased with decrease in temperature in a similar manner with methylcellulose. C. albidum mucilage when used as a binder in paracetamol tablet formulation induced faster onset of plastic deformation and higher amount of total plastic deformation than methylcellulose. The results of the tablet properties showed that the tensile strength, disintegration and dissolution times, increased with increase in binder concentration while friability decreased. Tablets containing chrysophyllum mucilage as binder also had lower tensile strength, disintegration and dissolution times but higher friability values than those containing methylcellulose. However, tablets containing chrysophyllum mucilage at low concentrations conformed to pharmacopeial standard on disintegration indicating its potential usefulness as binder for immediate release tablets. Thus, C. albidum mucilage could be used as an alternative binding agent in pharmaceutical tablets.

Use of Ternary Diagram in Formulation Design of Paracetamol Tablets

The development of a drug into a stable and marketable product involves many stages and processes using various equipment and experimental designs, and these have taken a toll on the cost and time it takes to produce such products. It will be desirable to develop a process that can shorten the time and cost using minimal facility. The ternary diagram was used to develop such a tool chart that could be used to study the effect of formulation factors; binder, disintegrant and compression pressure on tablet properties with a view to predicting tablet characteristics. The values of each factor (less than to greater than the maximum used in tablet formulations) were plotted along each axis of the three sides of the ternary diagram. Points were selected randomly within the ternary diagram to obtain concentrations or values to be used for each factor in tablet formulation. Paracetamol tablets (500 mg) were formulated by wet granulation to give a total tablet weight of 700 mg. The tablets were evaluated for friability, hardness, disintegration time and weight variation. Regions on a ternary diagram that produced tablets batches that passed disintegration time test were delineated as satisfactory while those that failed were delineated as unsatisfactory. Subsequently, new tablet batches were formulated according to values of selected points along tie-lines drawn across satisfactory and unsatisfactory regions on two sides of the diagram. The tablets were evaluated for tablet properties in which results showed that tablets batches made from satisfactory regions passed while those from unsatisfactory regions failed. Thus ternary diagram could be used as a tool to select formulation factor values for making acceptable tablets.

Development and validation of a liquid chromatographic method for estimation of dicyclomine hydrochloride, mefenamic Acid and paracetamol in tablets.

Liquid chromatographic method was developed for simultaneous quantitative determination of dicyclomine hydrochloride, mefenamic acid and paracetamol in their combined dosage form. The separation was achieved using a C18 column (250×4.6 mm id, 5 μm) using acetonitrile:20 mM potassium dihydrogen phosphate 70:30 (v/v) adjusted to pH 4 using orthophosphoric acid as mobile phase at a flow rate of 1 ml/min and detection at 220 nm. Separation was completed within 12 min. The retention times of dicyclomine hydrochloride, mefenamic acid and paracetamol were 3.8, 9.3 and 2.5 minutes respectively. The proposed method was found to have linearity in concentration range of 10-100 μg/ml for dicyclomine hydrochloride, 0.05-10 μg/ml for mefenamic acid and 0.1-20 μg/ml for paracetamol. The developed method has been statistically validated and was found to be simple, precise, reproducible and accurate. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form.

Use of thin-layer chromatography to detect counterfeit sulfadoxine/pyrimethamine tablets with the wrong active ingredient in Malawi.

BackgroundSubstandard and falsified anti-malarial medicines pose a serious threat to public health, especially in low-income countries. Appropriate technologies for drug quality analysis in resource-limited settings are important for the surveillance of the formal and informal drug market. The feasibility of thin-layer chromatography (TLC) with different solvent systems was tested using the GPHF Minilab in a study of the quality of sulfadoxine/pyrimethamine tablets in Malawi.MethodsTwenty eight samples of sulfadoxine/pyrimethamine tablets were collected from randomly selected health facilities of four districts of southern Malawi. A mystery shopper approach was used when collecting samples from illegal street vendors, and an overt approach for the other facilities. Samples were subjected to visual inspection, disintegration testing and TLC analysis. 10 samples were further investigated according to the methods of the US Pharmacopeia using high performance liquid chromatography (HPLC).ResultsOne sample was found to be falsified, containing a mixture of paracetamol tablets and co-trimoxazole tablets. These had been repackaged into paper strip packs labelled as a brand of sulfadoxine/pyrimethamine. TLC with different solvent systems readily proved that these tablets did not comply with their declaration, and provided strong evidence for the active pharmaceutical ingredients which were actually contained. Full pharmacopeial analysis by HPLC confirmed the results suggested by TLC for this sample, and showed two further samples to be of substandard quality.ConclusionsDue to the absence of the declared anti-malarial ingredients and due to the presence of other pharmaceutical ingredients, the identified falsified medicine represents a serious health risk for the population. Thin-layer chromatography (TLC) using different solvent systems proved to be a powerful method for the identification of this type of counterfeiting, presenting a simple and affordable technology for use in resource-limited settings.

Novel pure component contribution, mean centering of ratio spectra and factor based algorithms for simultaneous resolution and quantification of overlapped spectral signals: An application to recently co-formulated tablets of chlorzoxazone, aceclofenac and paracetamol

In this work, resolution and quantitation of spectral signals are achieved by several univariate and multivariate techniques. The novel pure component contribution algorithm (PCCA) along with mean centering of ratio spectra (MCR) and the factor based partial least squares (PLS) algorithms were developed for simultaneous determination of chlorzoxazone (CXZ), aceclofenac (ACF) and paracetamol (PAR) in their pure form and recently co-formulated tablets. The PCCA method allows the determination of each drug at its λmax. While, the mean centered values at 230, 302 and 253nm, were used for quantification of CXZ, ACF and PAR, respectively, by MCR method. Partial least-squares (PLS) algorithm was applied as a multivariate calibration method. The three methods were successfully applied for determination of CXZ, ACF and PAR in pure form and tablets. Good linear relationships were obtained in the ranges of 2–50, 2–40 and 2–30μgmL−1 for CXZ, ACF and PAR, in order, by both PCCA and MCR, while the PLS model was built for the three compounds each in the range of 2–10μgmL−1. The results obtained from the proposed methods were statistically compared with a reported one. PCCA and MCR methods were validated according to ICH guidelines, while PLS method was validated by both cross validation and an independent data set. They are found suitable for the determination of the studied drugs in bulk powder and tablets.

Fast analysis of caffeine in beverages and drugs by paper spray tandem mass spectrometry.

A simple and fast method based on paper spray mass spectrometry for the determination of caffeine in commercial beverages and drugs has been developed; the analyses were carried out in MRM mode, monitoring the transitions m/z 195 → m/z 138 for caffeine and m/z 198 → m/z 140 for the labeled internal standard. To verify the reliability of the proposed approach, a spiked sample (soda drink and paracetamol tablet) with a known amount of caffeine has been prepared and analyzed by PS-MS, providing accuracy values about 100%; the LOQ and LOD values were calculated at 1.2 and 1.6μg/mL, respectively. Both beverages and drugs were also analyzed with the classic analytical method based on LC-UV measurements, showing consistent results between the two approaches, thus confirming the reliability of the developed ambient MS determination. Graphical Abstract The assay of caffeine by paper mass spectrometry.

Durio Zibethinus L. (Malvaceae) Seed Gum: Extraction, Characterization, And Evaluation As Paracetamol Tablet Binder

Durio zibethinus L. (Malvaceae) also known as “Durian” in the Philippines is an evergreen tropical tree found mainly in the regions of Mindanao and Sulu. One-fourth of the fruits' mass is composed of seeds which is usually discarded [1]. This study aimed to determine the binding efficacy of extracted Puyat variety of Durian seed gum in Paracetamol tablet formulation. Durian seed gum was extracted consecutively using petroleum ether, ethanol and 1% acetic acid. Yielded seed gum extract was characterized in terms of its physicochemical properties. An acute oral toxicity study was done. Differential scanning calorimeter was used to test the compatibility of Durian seed gum with Paracetamol and its excipient. Different batches of Paracetamol tablet was formulated using Durian seed gum, PVP K-30, Acacia, and Corn starch as binder. Physical evaluation was done on the Paracetamol granules and comparative analysis showing the effectiveness of Durian seed gum in contrast with standard binders was evaluated through quality control tests like hardness, friability, disintegration, and dissolution test. The result of the study showed that Durian seed gum possesses good physicochemical properties. It is non-toxic and compatible with Paracetamol and its excipient. The formulation containing 9% w/w of unheated Durian seed gum as binder showed good binding efficacy with a friability of 0.74%. It displayed the highest dissolution rate (101.3%) and shorter disintegration time (10.96 minutes) compared with Acacia (40.44) and PVP K-30 (41.35). The results suggest that it can be used as binder in immediate released tablets. Whereas, 9% w/w heated Durian seed gum exhibited highest binding efficacy with a friability of 0.15% and a hardness of 184.87 N. The result shows that it can be used as a binder for sustained released tablets.

Paracetamol 325mg/tramadol 37.5mg effect on pain during needle electromyography: a double-blind crossover clinical trial.

Needle insertion during electromyography (EMG) may cause varying levels of pain that could lead to inaccurate assessment and premature termination of the procedure. The aim of this study is to compare paracetamol 325mg/tramadol 37.5mg with placebo in relieving pain before EMG. This is a randomized, crossover, placebo-controlled, double-blind clinical trial; forty-four healthy individuals, including 27 males with a mean age of 35.3years (range 18-59years), entered this study. The needles were inserted unilaterally 2h after administration of two analgesic tablets of paracetamol 325mg/tramadol 37.5mg or two placebo tablets. The pain was scored through a 100-mm visual analog scale (VAS) immediately and 2h after the procedure. The side effects were also recorded. Within a week, the procedure was repeated on the other upper limb, changing the treatment and placebo. The immediate and 2-h VAS scores were notably lower after administration of treatment compared to placebo (immediate pain: 17.5±12.8 vs. 32.1±16.0, P<0.001; and 2-h pain: 1.6±5.6 vs. 5.8±7.9, P=0. 002). There was a higher prevalence of side effects when treatment was used (48 vs. 9%, P<0.001). Although most symptoms were mild, transient and resolved without medical interventions, on one occasion a volunteer experienced brief loss of consciousness and one subject had severe vertigo that required hospitalization and fluid therapy. Paracetamol 325mg/tramadol 37.5mg administration prior to EMG could effectively alleviate pain. Further application of this medication in patients with neuromuscular disorders would warrant additional clinical trials, particularly considering the adverse events.

Adult tonsillectomy: postoperative pain depends on indications

IntroductionIntense pain is one of the most important postoperative complaints after tonsillectomy. It is often described by patients as comparable to the pain that accompanies an acute tonsillitis. Although recurrent tonsillitis is the most frequent indication for surgery, many tonsillectomies are performed due to other indications and these patients may be unfamiliar with such pain. ObjectiveTo verify whether individuals with recurrent tonsillitis experience different post-tonsillectomy pain intensity than those with other indications for surgery, with no history of episodes of acute tonsillitis. MethodsA total of 61 tonsillectomies were performed under general anesthesia, using a potassium titanyl phosphate (KTP) laser (to eliminate the potential influence on the study results of forceful dissection of fibrotic tonsils in patients with history of recurrent tonsillitis) and multiple ligations of blood vessels within the tonsillar beds. The patients received 37.5mg Tramadoli hydrochloridum+325mg Paracetamol tablets for 10 days. Postoperative variables included the duration of hospital stay, postoperative hemorrhage and readmission rate. The patients reported pain intensity on consecutive days, pain duration, weight loss on postoperative day 10, character, intensity and duration of swallowing difficulties, and the need for additional doses of painkillers. Healing was also assessed. Capsular nerve fibers were histologically examined in the resected tonsils by immunostainings for general and sensory markers. ResultsIndications for the surgery were: recurrent acute tonsillitis (34 patients), no history of recurrent tonsillitis: focus tonsil (20) and intense malodour (7). Pain intensity on postoperative days 3–4 and incidence of readmissions due to dehydration were significantly higher in the group with no history of recurrent tonsillitis. No significant differences in relative densities of protein gene product (PGP) 9.5- and calcitonin gene-related peptide (CGRP)-immunoreactive nerve fibers were observed. ConclusionPatients with recurrent tonsillitis qualified for tonsillectomy reported lower pain intensity than those without recurrent tonsillitis and the pain scores were unrelated to nerve fibers density.

Evaluation of microbial quality of selected blister-packed paracetamol tablets and paracetamol syrups marketed in Nigeria

Ten brands of blister-packed paracetamol tablet and twenty brands of paracetamol syrup marketed in Nigeria were evaluated for their microbial quality. While no microbial contaminant was isolated from all blistered-packed paracetamol tablets, ten of syrups were contaminated with organisms such as Escherichia coli , Klebsiellaspp , Pseudomonas aeruginosa and Staphylococcus aureus at 14.3, 21.4, 21.4 and 42.9% occurrence respectively. Penicilliumspp was isolated from two brands. Antibiotic susceptibility profile revealed all bacterial isolates to be multidrug resistant with Escherichia coli resistant to all antibiotics tested, while Staphylococcus aureus isolates were sensitive to Oxacillin, Cefuroxime and vancomycin. Pseudomonas aeruginosa isolates were sensitive to ofloxacin and gentamycin while Klebsiella isolates were sensitive to ofloxacin and nitrofurantoin. The study concluded that compliance with the provisions of good manufacturing practice as well as good quality control play role in determining the microbial bioburden of pharmaceutical products while isolation of multi-drug resistant organisms calls for establishment and adherence to antibiotics use policy in Nigeria. Keywords: Blister-pack, multidrug resistance, good manufacturing practice, quality control, bioburden

ISOLATION AND EVALUATION OF SEED COAT CONSTITUENTS OF MORINGA OLEIFERA

Traditionally, Moringa oleifera seed powder has been used as eco-friendly clarifying agent for drinking water. Natural polysaccharides are widely used as excipients in pharmaceutical industry. In the present In vitro study, starch and protein-mucilage fractions were isolated from the seed coats of Moringa oleifera. The isolated fractions were evaluated as binder and disintegrant in the preparation of paracetamol tablets. The prepared tablets were assessed for comparative In vitro quality control parameters such as weight variation, hardness, friability and disintegration time. The parameters were compared with paracetamol tablets prepared using potato starch as binder and disintegrant. Significant variation was observed in hardness, friability, and disintegration time among three formulations. Paracetamol tablets with protein-mucilage fraction were found to be relatively harder, less friable, and taking more time to disintegrate than the tablets made with potato starch. The tablets with isolated starch fraction were found to be almost similar to tablets prepared with potato starch with respect to hardness, friability and disintegration time. The isolated starch fraction and protein-mucilage fractions exhibited good binding and disintegrating properties and were natural in origin, nontoxic, biodegradable and bio compatible. Hence, they could be employed as binding and disintegrating agents in the formulation of paracetamol immediate release dosage forms. Since the protein fraction showed relatively higher values of hardness and disintegration time with less friability and could be explored for designing sustained release paracetamol tablets. Key words: Moringa seeds, starch fraction, protein-mucilage fraction, Paracetamol tablets, binder and disintegrant Â

Lubricating Properties of Co-processed Coconut Oil in Paracetamol Tablets Formulation

Objective: Lubricants are additives which reduce friction and so essential components of drug formulation. This piece of work was initiated to evaluate coconut oil as a co-processed lubricant in the formulation and compression of paracetamol tablets in comparison with magnesium stearate-talc as standard lubricant. Methods: Various concentrations 0.5, 1.5, 2.0 and 2.5% w/w lubricant mixtures of magnesium stearate-talc (MT), coconut magnesium stearate-talc (CMT), magnesium stearate (M), coconut oil alone (C) respectively; and without lubricant (None) which served as control were thoroughly mixed with granules (200 mg) prepared from the basic formula for paracetamol tablets which contained 85% w/w, 5% w/w and 10% w/w of paracetamol powder, corn starch and lactose respectively. The mechanical properties of tablets produced were evaluated using crushing strength, friability and crushing strength -friability ratio while the release properties of tablets were evaluated using disintegration and dissolution tests. Results: Granules lubricated with coconut oil co-processed with magnesium stearate had excellent flow. The crushing strength obtained for all the paracetamol tablets had acceptable values ranging from 4.82 to 6.85 kgf except for tablets lubricated with coconut oil alone. Generally, as the crushing strength values increased the friability decreased. Friability values for all the tablets generally decreased with increasing tablet lubricant concentrations of 2.0% w/w and 2.5% w/w though falling within range considered for conventional tablets. The disintegration time increased with increase in lubricant concentration as all the tablets had acceptable values. Tablets lubricated with coconut oil mixed with magnesium stearate-talc showed the highest CSFR/DT ratio. As the concentration of lubricant increased, there was a general decrease in the rate and extent of the drug release from the formulation. Conclusion: Coconut oil is an effective lubricant which can be processed with magnesium stearate and talc for an effective lubrication of granules before compression into pharmaceutical tablets.

Bioavailability Study of Sustain Release Preparations of Three Widely used NSAIDS Available in Bangladesh

This research has been designed to assess the in vitro bioavailability study of widely distributed and commonly used three analgesic and anti-pyretic drugs namely Diclofenac Sodium, Paracetamol and Ibuprofen sustained release tablets. Three brands of Diclofenac Sodium, four brands of Paracetamol and three brands of Ibuprofen tablets were obtained. Three brands of Diclofenac SR tablets, all brands maintained a steady state release pattern throughout the defined period, i.e. 12 hours. In 1st hour sample D01, D02, D03 were released 43.6%, 36.16%, and 59.85% of drug in dissolution respectively. Four brands of Paracetamol SR tablets, all brands maintained a steady state release pattern throughout the defined period, i.e. 12 hours. In 1st hour sample P01, P02, P03 and P04 were released 78.60%, 89.36%, 74.21%, 78.14 of drug in phosphate buffer (pH 6.8) respectively. Another sustained release tablets was Ibuprofen; all brands maintained a steady state release pattern trough out the defined period, i.e. 12 hours. In 1st hour sample I01, I02, I03 were released 60.46%, 54.02%, 50.57% of drug in phosphate buffer (pH 6.8) respectively. The release rates of the samples were determined for around 12th hours.

How well are national guidelines relating to the general sales of aspirin and paracetamol, adhered to by retail stores: a mystery shopper study

ObjectiveTo determine whether non-pharmaceutical retail outlets are aboding to the current Medicines and Healthcare products Regulatory Agency (MHRA) national guidelines for over-the-counter (OTC) sales of aspirin and paracetamol.MethodsStages 1 and...

Novel applications of locally sourced montmorillonite (MMT) clay as a disintegrant in the formulation of pharmaceutical product

This work explores the application of a locally sourced raw material, montmorillonite (MMT) clay, as a disintegrant in the formulation of an analgesic pharmaceutical product - paracetamol. The raw MMT was refined and treated with 0.IM NaCl to yield sodium montmorillonite (NaMMT) and the powder properties established in this work were compared with those of purified kaolinite (KO) clay and a reference standard disintegrant – maize starch (MS). Separately, the NaMMT, KO and MS powders were employed as disintegrants to compound paracetamol tablets. Some of the physical properties of the tablets were determined. Results of some powder properties showed that NaMMT and KO had superior angles of repose (40.20º and 34.40º, respectively) compared with the reference standard disintegrant MS (56.00%). Sodium montmorillonite (NaMMT) showed better swelling capacity (1.81) than both KO and MS (1.40 and 1.56, respectively), while MS and NaMMT exhibited comparable water retention capacity (3.04% and 2.90%, respectively). The porosity of MS (31.94%) was only slightly better than that of NaMMT (30.00%). For the physical properties of the tablets, the dissolution characteristic of NaMMT was slightly better than that of MS: for example, the percentage amount of 15% NaMMT and MS dissolved in 0.1M HCl solution at 30minutes duration were 75.40% and 74.10%, respectively; and at 50 minutes duration, it was 85.10% and 82.10%, respectively. On the other hand, the disintegration property of MS (1.54min) was slightly better than that of NaMMT (2.10min). Kaolinite (KO) failed both the dissolution and integration tests, with only 0.31% dissolving even after 1hr and requiring more than 30min to disintegrate. The friability and hardness tests showed that NaMMT was superior to both MS and KO. Overall, the sodium montmorillonite (NaMMT) was found to hold strong prospect as a disintegrant in the formulation and compounding of certain solid, compact pharmaceutical dosages.Keywords: Compact dosages, disintegrants, local raw material, montmorillonite clay, pharmaceutics.

Evaluation of the disintegrant properties of native and modified forms of fonio and sweet potato starches

The effects of acid modification on the disintegrant properties of two native starches obtained from Digitaria exilis (white fonio) and Ipomea batatas (sweet potato) were evaluated in comparison with official corn starch in paracetamol tablet formulations. The starches were extracted from grains of white fonio and tubers of sweet potato, and modified by acid hydrolysis using 6% w/w hydrochloric acid for 48 h. The native and modified forms of the starches were employed as exo‐disintegrants in paracetamol tablet formulations at concentrations of 2.5, 5.0, and 10.0% w/w. The disintegrant properties were assessed using crushing strength (Cs), friability (Fr), disintegration time (DT), disintegrant efficiency ratio (DER), and the dimensionless quantity DERc. The results showed that crushing strength and friability of the tablets appeared to depend on the type, concentration, and nature of disintegrant used. Disintegration time generally decreased with increase in disintegrant concentration and the values complied with the pharmacopoeial standard for uncoated tablets (≤15 min). Tablets containing acid modified starches showed longer disintegration times than those containing the native starches although there were no significant differences (p &gt; 0.05) in the values. Acid modification generally increased the disintegration efficiency ratio (DER) of the formulations while the values of DERc indicated that sweet potato starch would be the most efficient disintegrant with greater ability to enhance the balance between the mechanical and disintegration properties of the tablet. Thus, the experimental starches compared well with corn starch as disintegrants and could be useful for commercial tablet formulations.