British Pharmacopoeia Specifications Research Articles

Formulation and evaluation of fast dissolving tablets of haloperidol solid dispersion

PurposeThe aim of this study was to design fast dissolving tablets (FDT) of the anti –psychiatric drug haloperidol in solid dispersion forms as a way to enhance its dissolution profile and anti-psychiatric effect. MethodsSolubility studies of haloperidol in various polymers solutions were investigated. The selected polymer with high drug solubility (Poly ethylene glycol 4000) was used for preparation of solid dispersion through two methods solvent evaporation method and melting method. Haloperidol solid dispersion mixed with other solid powder excipients and compressed into tablets. The resulted tablets were evaluated according to British Pharmacopoeia (B.P.) specifications. Pre- and post -compression studies were performed to determine the flow properties and evaluate the solid dispersion systems, followed by in vivo studies through forced swimming test (FST) ResultsPre-compression studies showed adequate flowability and compatibility of polymer and solid excipients with haloperidol. The selected solid dispersion tablet (SD2) demonstrated the best disintegration and water absorption ratio in addition to satisfactory friability and hardness. Attempts of in vitro dissolution results and thermodynamic stability studies showed acceptable results for (SD2) formulation containing PEG 4000 polymer prepared by melting method.The in vivo study of (SD2) formulation revealed the highest immobility time to rats compared to control rats and others treated with commercial haloperidol product. ConclusionFast dissolving tablets prepared from solid dispersion of haloperidol with PEG4000 expressed rapid onset of action with enhanced anti-psychiatric effect of haloperidol.

Characterization of Physicochemical and Micromeritics Properties of Carboxymethylated Starches Derived from Vigna unguiculata Seeds and Pennisetum glaucum Grains with an Intermediate Degree of Substitution

Conventional commercial sources of starch for industrial applications are mainly based on staple foods, due to the worsening economic situation, there is a need to explore other underutilized unconventional sources. This study aims to extract, modify, and characterize starch from unconventional sources: cowpea (Vigna unguiculata) seeds and pearl millet (Pennisetum glaucum) grains. Starch was extracted from cowpea seeds and pearl millet grains by milling and precipitation in sodium hydroxide solution and water respectively. Carboxymethylation of the starch was carried out using monochloroacetic acid. The native starch, modified starches, and commercial brand-sodium starch glycolate were subjected to physicochemical and micromeritic characterization as well as spectroscopic and thermal analysis. The starch yields of 16.01 and 46.60% were obtained from cowpea seeds and pearl millet grains respectively. Starch samples with an intermediate degree of substitution (0.52-0.60) were obtained from both sources. The starch samples complied with British Pharmacopoeia specification and carboxymethylation generally resulted in improved properties (reduced gelatinization temperature, increased swelling capacity and flow properties). The pearl millet was made of oval-shaped granules with higher starch yield, reduced moisture content, and improved flow than the owpea starch, however, the latter contained cuboid-shaped granules, had higher densities, and reduced redispersion time. Carboxymethyl functional group was introduced, and the structure of starch was intact upon modification. Carboxymethyl starches obtained from cowpea seeds and pearl millet grains have desirable properties and can be potential sources of low-cost excipients for pharmaceutical formulations.

Development and Evaluation of Fast Dissolving Liquisolid Haloperidol Tablets

Aim: The aim of this study was to design fast dissolving tablets (FDT) of the anti -psychiatric drug, Haloperidol in liquisolid forms as a way to enhance its dissolution profile and anti-psychiatric effect.
 Methodology: Solubility studies of Haloperidol in various solvents and surfactants were conducted. The solvent with high solubilizing ability was tween 20 (80%), selected and absorbed into the carrier and then coating material added with other solid powder excipients, finally all powder compressed into tablets. The resulting liquisolid tablets were evaluated according to British Pharmacopoeia (B.P.) specifications. Pre- and post-compression studies were performed to determine the flow properties and evaluate the liquisolid systems, followed by in vivo studies through forced swimming test (FST).
 Results: Pre-compression studies showed adequate flowability and compatibility of liquid and solid excipients with haloperidol. The selected liquisolid tablet (LS4) demonstrated the best disintegration and water absorption ratio in addition to satisfactory friability and hardness. Attempts of in vivo dissolution results and thermodynamic stability studies showed acceptable results for the F4 formulation containing 80% Tween 20,Avicel and aerosel (0.22:81.6:10.2%), respectively. The in vivo study of (LS4) formulation revealed the highest immobility time to rats compared to control rats and others treated with purchased halonace®.
 Conclusion: Fast dissolving liquisolid tablets expressed rapid onset of action with enhanced anti-psychiatric effect of haloperidol.

Physicochemical properties of various alginate-based raft-forming antacid products: a comparative study

Background: Alginate-based, raft-forming antacid products with reflux suppressant activity are complex formulations expected to achieve effective raft formation and cause elimination or displacement of the acid pocket, which is typically manifested in gastroesophageal reflux disease (GERD).Methods: In the present study, six alginate-based raft-forming products commercially available in the Indian market were compared in terms of their acid neutralization properties, strength, resilience and structural and thermal properties of their rafts. Percent alginate content was also determined.Results: Rafts of products containing calcium-based antacids formed voluminous, porous and floating rafts within seconds of addition to the simulated gastric fluid (SGF) compared with the products that contained aluminium and magnesium-based antacids. Marked differences were not evident in the ANC (acid neutralization capacity) values of the various products. No correlation was observed between ANC and raft-forming capacity or duration of neutralization. Raft structures affected their neutralization profiles. Rafts of porous and absorbent nature could retain their ANC probably due to release of trapped antacids. Further, raft strengths of only two products were above the British Pharmacopoeia specification of not less than 7.5 g. Sodium alginate content was within specifications (85-115%) for three of the six products.Conclusions: Raft-forming formulations with higher alginate content and calcium-based antacids have better physicochemical properties such as ANC, neutralization profiles, raft strength and raft resilience than those with lower alginate content or those containing aluminium or magnesium-based antacids.

Microbiological contamination of herbal medicinal products marketed in Kenya for chronic diseases: A case study of Nairobi metropolis

Herbal medicines’ use is steadily increasing globally, thus creating a compelling need for quality assurance. The present study assessed the microbial contamination of 86 herbal preparations marketed in the Nairobi metropolis used in the management of chronic diseases. Aqueous suspensions of each herbal product were inoculated into agar and evaluated for bacterial and fungal growth. Discrete colonies were transferred to selective media by streak-plate technique for differential analysis. Twenty-eight (32.6 %) products failed to comply with the British Pharmacopoeia (2019) specifications for microbial load. Twenty-six (30.2 %) herbal products, were contaminated with bile-tolerant Enterobacteriaceae. A total of 41 bacterial isolates, including 14 (34.1 %) E. coli, 10 (24.4 %) Salmonella spp. and 17 (41.5 %) undetermined bile-tolerant Enterobacteriaceae, were identified from the 26 herbal products. Overall, 41 (47.7 %) products were non-compliant with pharmacopoeial specifications for microbiological quality. Results of this study imply herbal medicines are heavily contaminated with pathogenic microbes thus underscoring the need for stringent quality assurance policies to safeguard the public from low quality and contaminated herbal medicines.

Application of microcrystalline cellulose obtained from Gossypium herbaceum in direct compression of chlorpheniramine maleate tablets

The flow, tableting and in vitro release properties of directly compressed chlorpheniramine maleate (CPM) tablets containing fluid bed dried and lyophilized microcrystalline cellulose (MCC) obtained from Gossypium herbaceum (GH) were investigated. Delignification of dried GH linters was done through the soda process to obtain alpha cellulose which was hydrolyzed with 2.0 N hydrochloric acid to get MCC. The MCC was washed with water until neutral. Drying was done by either fluid bed method or lyophilization to obtain MCC-GossF and MCC-GossL respectively. Chlorpheniramine tablets containing 20, 30 and 40% of the MCCs were prepared by direct compression method. Avicel PH102 (AVH-102) served as comparing standard. Using standard methods, evaluation of the powders and the tablets was done. The evaluated parameters of the powders and tablets conformed to the British Pharmacopoeia specifications. The CPM tablets containing MCC-GossF (coded CGF) had better flow but were not mechanically as strong as those containing MCC-GossL (coded CGL). The hardness and disintegration times of the tablets were in the order of CGF < CGL and the friability was in the order of CGF > CGL. Similar parameters of DCL compared well with CPM tablets containing AVH-102 (coded DAV). The MCC obtained from GH had dilution potential up to 40% except in CGF-4 tablets. The in vitro dissolution showed > 80% CPM release from all the batches within 30 min. The release kinetics were of mixed order while the mechanism of drug release was Fickian. The MCCs served as good directly compressible binder for chlorpheniramine maleate.

Quantifying the Effects of Vibration on Medicines in Transit Caused by Fixed-Wing and Multi-Copter Drones

The concept of transporting medical products by drone is gaining a lot of interest amongst the medical and logistics communities. Such innovation has generated several questions, a key one being the potential effects of flight on the stability of medical products. The aims of this study were to quantify the vibration present within drone flight, study its effect on the quality of the medical insulin through live flight trials, and compare the effects of vibration from drone flight with traditional road transport. Three trials took place in which insulin ampoules and mock blood stocks were transported to site and flown using industry standard packaging by a fixed-wing or a multi-copter drone. Triaxial vibration measurements were acquired, both in-flight and during road transit, from which overall levels and frequency spectra were derived. British Pharmacopeia quality tests were undertaken in which the UV spectra of the flown insulin samples were compared to controls of known turbidity. In-flight vibration levels in both the drone types exceeded road induced levels by up to a factor of three, and predominant vibration occurred at significantly higher frequencies. Flown samples gave clear insulin solutions that met the British Pharmacopoeia specification, and no aggregation of insulin was detected.

In vitro quality assessment of ten brands of metronidazole benzoate suspensions marketed in Warri, Nigeria

Therapeutic failure as a result of high incidence of fake, adulterated, counterfeit and substandard drugs usage is a major concern to health practitioners, drug regulatory agencies, drug consumers and the general public in Nigeria. The objective of this study was to carry out in vitro quality assessment/evaluation of ten (10) different brands of metronidazole benzoate suspensions that are marketed in Warri, Nigeria. Metronidazole benzoate suspensions (10 brands) were purchased from some pharmacies in Warri, Nigeria. They were checked for the label information on both the secondary and primary packages, physical examination of the primary containers for tampering/breakage of seal on cap, organoleptic properties, pH, sedimentation volume, flow rate, viscosity, redispersibility and content of active ingredient/assay using standard methods. Results obtained showed that the suspensions had the necessary information on their labels, the containers were not tampered with in order to access or change their content. All the brands tested showed good results for color variation, pH, viscosity, flow rate, sedimentation, and redispersibility. All the brands met with their label claims of metronidazole benzoate content based on British Pharmacopoeia specification [95 - 105 %] except one brand (MET-A), that failed. Generally, nine of the brands representing 90 % met with their label claim and can be considered fit for distribution and consumption.

Evaluation of the sustained release potential of a co-processed excipient in Ibuprofen tablet formulation

Background: The oral route happens to be the most preferred route among the various routes of drug delivery. However, the conventional dosage form has few limitations which could be resolved by modifying the existing dosage form. Sustained and controlled drug delivery systems help to maintain constant plasma drug concentration and retarding the release rate of drug thereby extending the duration of action. Objectives: To develop by co-processing technique a two-component excipient and evaluate its sustained release potential in ibuprofen tablet formulation. Method: Maize starch (MS) was co-processed with polyvinylpyrrolidone (PVP), acacia powder (ACA) and hydroxypropyl methylcellulose (HPMC) respectively at a ratio of 60:40 using the co-fusion method. The granules so formed were analyzed for flow properties and compatibility tests based on; angle of repose, flow rate, bulk and tapped densities (BD/TD), Hausner ratio (HR) and Carr’s Index (CI), Differential Scanning Calorimetry (DSC) and Fourier Transform Infra-red (FTIR) spectroscopy. The tablets were evaluated after compression by direct compression. Results: The co-processed excipient (CE) had excellent flow properties as compared to the physical mix (PM). The DSC thermograms and FTIR spectra of CE when compared with their individual excipients and that of the drug, showed a similarity in their endothermic peaks respectively but for some slight difference showing compatibility and no new compound was found because of co-processing. The tablets had acceptable values for weight variation and disintegration time. Tablets of Batch XII B were of good quality regarding weight, hardness, disintegration time and friability by meeting the British Pharmacopoeia specifications. Conclusion: This study concluded that the two-component excipients developed improved the functionality of the single components. Conversely, the co-processed excipients did not exhibit good sustained release property but would be better employed as conventional tablets or prepared as a sustained release matrix formulation.

Effects of a co-processed novel multifunctional excipient on the tablet properties of metronidazole

Purpose: The objective of this work was to formulate and determine the effects of a co-processed novel, multifunctional pharmaceutical excipient on tablet parameters of metronidazole tablets produced by direct compression. Methods: The excipient was prepared by co-processing lactose, mucin and gelatin in a ratio of 90:1:9, dried and pulverized into powder using the co-fusion method. The excipient formulated was characterized using Differential scanning calorimetry (DSC) and Fourier transform infra-red spectroscopy (FTIR). The excipient was used to prepare metronidazole tablets and compared with other modified excipients like Cellactose® and Spray dried lactose®. Parameters evaluated on tablets include crushing strength, friability, disintegration, tablet assay and in-vitro studies. Results: DSC analysis revealed a crystalline excipient due to the high content of lactose in the formulation while FTIR showed no interaction between the excipient and metronidazole showing compatibility. Tablets prepared had an average weight of 0.49 g, crushing strength of 4.3 KgF, friability of 0.65 %, disintegration time of 14 min and time taken for 50 % of the drug to be released was 14 min. Conclusion: A multifunctional co-processed excipient having a filler-binder-lubricant property was prepared. The drug-excipient ratio (40:60) of the co-processed excipient gave pharmaceutically acceptable tablets that met the British Pharmacopoeia specifications as well as compared well with the modified excipients used due to improvement in the flow property as a result of co-processing. Keywords: co-processing, excipient, metronidazole, co-fusion

The Mechanical and In vitro Release Properties of Diazepam from Tablets Containing Fluid Bed Dried and Lyophilized Cocos nucifera Microcrystalline Cellulose

Aim: This study aimed to evaluate the mechanical and in vitro release properties of diazepam from tablets containing fluid bed dried and lyophilized microcrystalline cellulose (MCC) obtained from the matured fruit husks of Cocos nucifera (CN).
 Study Design: Method of experiment.
 Place and Duration of Study: Department of Pharmaceutical Technology and Industrial Pharmacy, University of Nigeria, Nsukka from March 2015 to September, 2016
 Methods: Dried CN fruit husks were digested in sodium hydroxide to obtain alpha (α) cellulose which on hydrolysis with mineral acid (Hydrochloric acid) solution gave CN-MCC. The dry MCC obtained by either fluid bed or lyophilized drying of the wet CN-MCC were coded MCCF-Cocos and MCCL-Cocos respectively. Both MCCs were used in the formulation of diazepam tablets at 20, 30 and 40% w/w. Avicel PH 102 (AVC-102), was used as comparing standard. The tablets were evaluated for physical and dissolution properties using standard methods.
 Results: Results show the tablets passed the British Pharmacopoeia specifications for weight uniformity, crushing strength, disintegration time, friability and dissolution. Diazepam tablets containing MCCL-Cocos (coded DCL) were mechanically stronger than those containing MCCF-Cocos (coded DCF). Disintegration time was in the order of DCF > DCL tablets while friability was in the order of DCL < DCF tablets. Diazepam tablets containing AVC-102 (coded DAV) were mechanically stronger than DCL and DCF tablets. The dilution potential was in the order DAV > DCL > DCF. More than 80% of the diazepam content was released from DAV, DCL and DCF tablets.
 Conclusion: Generally, DAV, DCL and DCF tablets met the British Pharmacopoeia limits for mechanical properties and in vitro drug release with DCL tablets showing significantly (P = .05) superior mechanical properties while DCF showed faster drug release.

Comparative quality assessment of generic brands of ceftriaxone sodium injection marketed in Ibadan, South- West Nigeria

Ceftriaxone is a broad-spectrum bactericidal agent. Due to lower prices of generic brands of ceftriaxone sodium as compared to the innovator brand, the populace mostly uses them and hence, the need to comprehensively investigate and compare the pharmaceutical quality of innovator with generic brands marketed in Ibadan, South-West Nigeria. Standard physical and chemical tests for quality control of parenterals as stipulated by the British Pharmacopoeia 2013 were performed on 13 brands. The basic functional groups were identified by Infrared spectrophotometry. A Liquid Chromatography method was used for quantitative determination of ceftriaxone sodium. The bactericidal activity of ceftriaxone sodium and brands were investigated by using clinical isolates of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Bacillus species. The FTIR spectra for the innovator and the generics were superimposable. For clarity test, almost all samples were observed to give a clear solution, but unclear solution was seen in samples B, E and I. The LC method was linear over a concentration range of 7.8125 – 250 μg/mL (r2 = 0.9996). Microbiological efficacy using MIC determination of the generic products evaluated against several clinically significant organisms gave conclusive results with the generic products showing equivalent efficacy to the reference formulation except in few cases. The results obtained from this study conform to that of the British Pharmacopoeia specifications, giving an indication that all the sampled generics are pharmaceutically equivalent. There is need to improve on local production and to increase the post-marketing surveillance, as some products do not have NAFDAC registration numbers.Keywords: Ceftriaxone; Physicochemical analysis; Pharmaceutical equivalence; Microbiological analysis

EVALUATION OF A MODIFIED BIOMATERIAL OF TYMPANOTONUS FUSCATA SHELL POWDER II: FORMULATION OF PYRIMETHAMINE AND PYRIDOXINE HYDROCHLORIDE TABLETS

A novel modified biomaterial of periwinkle shell powder, MBPSP was developed from Tympanotonus fuscata . It was assessed as a bulking agent in the formulation of pyrimethamine and pyridoxine hydrochloride tablets adopting dicalcium phosphate dihydrate (DCP) as a standard. A 100 g of the ground periwinkle shell was broken down in 166.0 ml of 2 M hydrochloric acid, clarified and treated with 5 M sodium hydroxide. The thick white precipitate obtained was washed severally and to it, ortho-phosphoric acid was dropped in bits until a thick, dehydrated bulk was attained which was dried at 60 o C and classified with 250 μm sieve. The product was coded MBPSP. Two batches of granules containing pyrimethamine (25 mg) and pyridoxine hydrochloride (50 mg) were generated by the wet granulation employing MBPSP alongside DCP. The granules were lubricated with magnesium stearate and talc and compacted into tablets at 7.55kN using a 10.50 mm diameter die and flat-faced punch fixed in a hydraulic hand press. The tablet produced were evaluated using the British Pharmacopoeia specifications. The weight variation for the pyrimethamine or pyridoxine hydrochloride tablets containing MBPSP or DCP were 0.06, 0.1, 0.097 and 0.143 % respectively. The total drug content for the individual lots of tablets for either pyrimethamine or pyridoxine hydrochloride was within 85.00-115.00 % of their label claim. Higher mechanical strength were noted for the batch of tablets manufactured with DCP and containing pyrimethamine and pyridoxine hydrochloride than MBPSP. Though the entire batches of tablets for the two drugs manufactured with either MBPSP or DCP disintegrated in less than 5.00 min with no significant difference in their individual disintegrating time (p>0.05), pyridoxine hydrochloride tablets prepared with DCP disintegrated in lesser time when compared to MBPSP (p<0.05). Only the pyrimethamine tablets prepared with MBPSP attained 75.00 % drug release in 45.00 min in line with the United States Pharmacopoeia (USP) criteria. Therefore, MBPSP could be another very useful bulking agent in the formulation of pyrimethamine immediate-release tablets by the wet granulation technique. Keywords : Modified biomaterial, Tympanotonus fuscata, periwinkle, shell, pyrimethamine, pyridoxine hydrochloride, tablet.

Upgrading of dissolution and anti-hypertensive effect of Carvedilol via two combined approaches: self-emulsification and liquisolid techniques

Objective: The aim of the study was to design a self-emulsifying drug delivery system (SEDDS) of the anti-hypertensive Carvedilol in liquid and liquisolid forms as a way to enhance its dissolution profile and anti-hypertensive effect.Methods: Solubility studies of Carvedilol in various oils, surfactants and co-surfactants were conducted, followed by the construction of pseudo-ternary phase diagrams and other in vitro assessments. The selected SEDDS formulation (S1) was adsorbed onto solid powder excipients and compressed into tablets. The resulting liquisolid tablets were evaluated under British Pharmacopoeia (B.P.) specifications. Pre- and post-compression studies were performed to determine the flow properties and evaluate the liquisolid systems, followed by in vivo studies in hypertensive rats.Results: Attempts of self-emulsification, droplet size, and thermodynamic stability studies showed acceptable results for the S1 formulation containing Capryol 90, Tween 20, and Transcutol HP (10:53.3:26.2%), respectively. Pre-compression studies showed adequate flowability and compatibility of liquid and solid excipients with Carvedilol. The selected liquisolid tablet (LS7) demonstrated the best disintegration and water absorption ratio in addition to satisfactory friability and hardness. A significantly (p < .05) fast dissolution rate was observed for both SEDDS and liquisolid formulations when compared to pure drug and marketed Carvepress®. The in vivo study of LS7 formulation revealed a rapid significant (p < .01) decrease in the mean arterial pressure (MAP) of the rats (112.72 mmHg) within the first 30 min followed by a further decline (107.22 mmHg) after 1 h when compared to Carvepress®.Conclusion: Self-emulsifying liquisolid tablets expressed rapid onset of action with enhanced anti-hypertensive effect of Carvedilol.

Investigating the physical stability of repackaged medicines stored into commercially available multicompartment compliance aids (MCAs).

BackgroundCompliance aids are devices which have been developed and are currently used to assist individuals in their medicines management. The use of compliance aids involves the transfer of medicines from the manufacturers' original packaging and repackaged into an multicompartment compliance aid (MCA). MCAs do not guarantee the same level of protection compared to manufacturer's original packaging.ObjectiveThe aim of this study was to investigate the stability profile of atenolol, aspirin and lansoprazole dosage forms repackaged together in two different commercially available MCAs.MethodsIn a laboratory in the United Kingdom, the physical stability of the formulations repackaged into two commercially available brands of MCAs was evaluated. After 8 weeks of storage (under controlled ambient conditions), changes in the disintegration (tablets only) and dissolution properties (all formulations) were examined in accordance with British Pharmacopoeia (BP) specifications.Key findingsFindings from this study confirm that changes in solid‐dosage form quality are observed when repackaged into MCAs compared to manufacturers packaging resulting in differences in in‐vitro dissolution performance. However, even with these changes, overall product performance was acceptable and within BP specifications.ConclusionThere is a need for greater collaboration in this area between manufacturers, hospital and community pharmacists, academics and policymakers to increase the data available on the physical stability and in turn performance of medicines repackaged into MCAs.

Evaluation of disintegration and dissolution of chloroquine tablets in some States in Northern Nigeria

The biological performance of tablets is commonly assessed by disintegration time and dissolution rates, which ascertains how much of the orally administered tablet may be bioavailable. This study seeks to assess the quality of chloroquine tablets in some States in Northern Nigeria by determining their disintegration and dissolution parameters. The Vanderkamp tablet disintegration tester was used to assess the disintegration time, while the dissolution rate test was carried out according to British Pharmacopoeia specifications. Five tablets of each coded sample were singly placed in a dry basket of the dissolution tester and the contents of which were immersed in a vessel containing one litre dissolution medium of de-aerated 0.1 HC1 at a constant temperature of 37±0.5°C. The stirring motor operated at 100 revolutions per minute for 45 minutes. The absorbance was measured in an UV spectrophotometer at a wavelength of 344 UM. Twenty-six (26), 36, 50 and 16 of the samples from states A, B, C and D respectively had normal disintegration times of less than 15 minutes. About 86% of the total samples from the 4 states disintegrated within 14 minutes thus conformed to the official requirement. States A (42.86%), B (67.57%), C (80.77%) and D (90.91%) samples had dissolution rate values above 70%. The disintegration time and dissolution rates of the sampled chloroquine tablets were assessed and found to have a good quality. However, quantitative drug assays need to be carried out that will measure the actual amount of active chloroquine in a tablet sample.Keywords: Chloroquine tablet, Disintegration, Dissolution

Sources and magnitude of error in preparing morphine infusions for nurse-patient controlled analgesia in a UK paediatric hospital.

Background Administering nurse/patient controlled analgesia (N/PCA) to children requires complex dose calculations and multiple manipulations to prepare morphine solutions in 50mL syringes for administration by continuous infusion with additional boluses. Objective To investigate current practice and accuracy during preparation of morphine N/PCA infusions in hospital theatres and wards at a UK children's hospital. Methods Direct observation of infusion preparation methods and morphine concentration quantification using UV-Vis spectrophotometry. The British Pharmacopoeia specification for morphine sulphate injection drug content (±7.5%) was used as a reference limit. Results Preparation of 153 morphine infusions for 128 paediatric patients was observed. Differences in preparation method were identified, with selection of inappropriate syringe size noted. Lack of appreciation of the existence of a volume overage (i.e. volume in excess of the nominal volume) in morphine ampoules was identified. Final volume of the infusion was greater than the target (50mL) in 33.3% of preparations. Of 78 infusions analysed, 61.5% had a morphine concentration outside 92.5-107.5% of label strength. Ten infusions deviated by more than 20%, with one by 100%. Conclusions Variation in morphine infusion preparation method was identified. Lack of appreciation of the volume overage in ampoules, volumetric accuracy of different syringe sizes and ability to perform large dilutions of small volumes were sources of inaccuracy in infusion concentration, resulting in patients receiving morphine doses higher or lower than prescribed.

Characterisation of a novel, multifunctional, co-processed excipient and its effect on release profile of paracetamol from tablets prepared by direct compression

ObjectiveTo characterise a novel multifunctional pharmaceutical excipient and investigate its effect on paracetamol release from tablets prepared by direct compression. MethodsThe excipient was prepared by co-processing gelatinized maize starch with sodium carboxymethyl cellulose and microcrystalline cellulose in a ratio of 2:1:1, dried and pulverized into powder. The excipient formulated was characterized using Fourier transform infrared spectroscopy and differential scanning calorimetry. The excipient was used to prepare batches of tablets by direct compression with drug-excipient ratios of 1:1, 1:2, 1:3 and 1:4. Parameters evaluated on tablets include crushing strength, friability and in vitro dissolution studies. ResultsDifferential scanning calorimetry analysis revealed a crystalline excipient while Fourier transform infrared spectroscopy showed no interaction between the excipient and paracetamol. Tablets from all the batches gave average crushing strength values between 3.47 and 4.88 kp. The 1:1 and 1:2 tablet batches were comparable to each other while 1:3 and 1:4 were also comparable to one another in their dissolution profiles. The dissolution parameters of the 1:4 batch was faster with – m∞ (90.5%), t50% (3.5 min), t70% (11.6 min) while that of ratio 1:1 was the least with – m∞ (48.6%), m5min (23.8%). Their release kinetics followed a Korsmeyer–Peppas model with a super case-II transport mechanism. ConclusionsThe drug-excipient ratios of 1:3 and 1:4 gave pharmaceutically acceptable tablets that met the British Pharmacopoeia specifications. The t50% value of the 1:4 batch of tablets may find its usefulness in formulating drugs for which a fast onset of action is desired.

Quality assessment of different brands of Diclofenac tablets in some pharmacy stores in Abuja

Diclofenac is one of the most commonly used non-steroidal anti-inflammatory drugs for the treatment of pain, rheumatism and other inflammatory conditions. The drug has analgesic, anti-pyritic and anti-inflammatory effects. Rapid and sensitive-reversed phase high performance liquid chromatography (HPLC) method was used to analyze the amount of Diclofenac in the samples. The calibration curve was linear with correlation coefficient (r2) of 0.9999 at concentration range of 10 to 80 µg/ml and coefficient of variance (CV %) of less than 5%. Percentage content of Diclofenac from the different pharmaceutical preparations was within 97.5 to 115.5%, but 42.86% failed with over range, while 57.14% passed the British Pharmacopoeia (BP) specification range of 95 to 105.0% of the prescribed content. The drug release profiles were evaluated in vitro using a dissolution test apparatus. The USP paddle method was used to perform the dissolution profiles of Diclofenac Sodium. From the result, there is still need for the policy markers in the country to checkmate the imports of different brands of pharmaceutical products into the Nigerian market, since almost 50% of the drug analyzed is above the stated amount claimed by the manufacturers. Key words: Diclofenac, reversed phase- high performance liquid chromatography (HPLC), ultraviolet (UV)-spectrophotometer, percentage content, Nigerian market.

Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana

ObjectivesGiven use of uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent uterotonics is indisputable. This study evaluated access to and potency of injectable uterotonics in Ghana.DesignStudy...