British Pharmacopoeia Research Articles

In vitro comparative quality evaluation of different brands of carbamazepine tablets commercially available in Dessie town, Northeast Ethiopia

BackgroundGood-quality drugs that fulfill the regulatory parameters and are produced per the current good manufacturing practice (cGMP) standards are very critical for the best therapeutic outcomes. However, the variety of branded drugs circulation in the market often put clinicians and pharmacists in a difficult situation of choice due to the possibility of interchangeability among brands, so we should ascertain the quality of the various brands of drugs, available in the drug market. The purpose of the study was to evaluate the quality and physicochemical equivalence of six brands of carbamazepine tablets that are commercially available in Dessie town, Northeast Ethiopia.MethodsAn experimental study design was used. Six different brands of carbamazepine tablets were purchased from community pharmacies in Dessie town, Northeast Ethiopia, which were selected using simple random sampling methods. Identification, weight variation, friability, hardness, disintegration, dissolution test, and assay for the content of active ingredients were evaluated according to the procedures described in the United States Pharmacopeia (USP) and British Pharmacopeia (BP), and the results were compared with USP and BP standards. The difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements.ResultsThe identification test results revealed that all samples contained the stated active pharmaceutical ingredients and all brands of carbamazepine tablets complied with the official specification for weight variation, friability, and hardness tests. The percentage concentration of carbamazepine was found in the range of 97.85 to 102.09, which met the USP specification of 92% to 108% of the stated amount. Similarly, all samples fulfilled disintegration time (i.e., ≤ 30 min) except brand CA1 (34.183 min) and dissolution tolerance limits (i.e., Q ≥ 75% at 60 min), which was found in the range of 91.673% -97.124%. The difference factor (f1) values were < 15 and the similarity factor (f2) values were > 50 for all the tested brands of carbamazepine tablets.ConclusionThe present study revealed that all brands of carbamazepine 200 mg tablets met the quality control parameters as per pharmacopoeial specifications except the disintegration test of brand CA1, and could be used each brand interchangeably to achieve the desired therapeutic effect.

A New Approach for Developing Spectrophotometric Determination of Phenylephrine Drug in Pure, Pharmaceutics and Serum Samples Using Sodium Periodate as Oxidizing Agent via a Green Method of CFIA/Merging Zone Technique

The research involved a rapid, automated and highly accurate developed CFIA/MZ technique for estimation of phenylephrine hydrochloride (PHE) in pure, dosage forms and biological sample. This method is based on oxidative coupling reaction of 2,4-dinitrophenylhydrazine (DNPH) with PHE in existence of sodium periodate as oxidizing agent in alkaline medium to form a red colored product at ʎmax )520 nm (. A flow rate of 4.3 mL.min-1 using distilled water as a carrier, the method of FIA proved to be as a sensitive and economic analytical tool for estimation of PHE. Within the concentration range of 5-300 μg.mL-1, a calibration curve was rectilinear, where the detection limit was 3.252 μg.mL-1, and the RSD% was 4.09. Recovery was 100.55% with a sample throughput of 62 sample/hr. The proposed method was successfully applied for determining PHE in serum samples and pharmaceutical formulations, the interference of excipients was studied. The mechanism of the chemical reaction has been proposed. When the suggested method's results were compared to those provided by a British Pharmacopeia reference method, there was no discernible difference between the two at the 95 percent confidence level.

Diazotizasyon ve Kuplaj Reaksiyonu ile Saf Form ve Farmasötik formülasyonlarda Mesalazin'in spektrofotometrik tayini

An accurate, simple, and precise spectrofluorimetric method is presented for the determination of Mesalazine (MZN) based on Diazotization in acidic medium through reaction it with Sodium nitrite (NaNO2) to result diazonium salt that Coupling Reaction in medium base with 2,7-Dihydroxynaphthalene (DHNP) to formed azo dye. The intensity of the dye was measured at 501 nm after optimization of the experimental parameters. Beer’s law was applied to the proposed method and it was valid within a concentration range of 0.25–10 μg/mL and the linear regression was R2 = 0.9974. The limit of quantitation was 0.0241 μg/mL, and the molar absorptivity coefficient 1.85x104 L.mol−1.cm−1. Sandal's sensitivity was 0.0082 μg.cm-2 There is no interference from excipients found in the tablet. The data were statistically compared with British Pharmacopoeia methods asstandard reference using Student's t-and F-test.

Spectrophotometric Determination of Vitamin B1 (Thia min Hydrochloride)In Pharmaceutical Preparation by Coupling Reaction with Diazotized Sulfanilic acid.

A simple, accurate and sensitive spectrophotometric method for the determination of vitamin B1 (hiamin hydrochloride) in aqueous solution is described. The method is based on the diazotization of sulfanilic acid followed by coupling with thiamin hydrochloride in the presence of sodium hydroxide to form reddish-brown water soluble dye that is stable and has maximum absorption at ( )",u*: 490nm ).The molarabsorptivity and sandell sensitivity were 7.74 x103 L.mol-l.cm-r and 0.045pg.cm-l respectively. The procedure is developed for bulk thiamin hydrochloride and some of their pharmaceutical preparalions. The are accurate, precise and comparable to the standard method (British pharmacopoeia).

Preliminary health risk assessment of two exudate gums as pharmaceutical excipients

Some exudate gums such as acacia and tragacanth gums have been certified to be used in pharmacy as excipients. In this study exudate gums, obtained from two local trees in Ghana: Cussonia arborea and Cordia mellinii, were assessed for their safety for use as pharmaceutical excipients. The crude gums were purified using water and 96% ethanol and digested by di-acid procedure using 65% HNO3 and 37% HCl (2:3) at 95 °C for elemental analysis. Quantification of Ca, Fe, Mg, Cu, Zn, Mn, Ni, Hg, Cd, Pb and As ions was done using AAS 400; Na and K using the single channel flame photometer; and P using Spectronic 20 spectrophotometer. Microbial quality of the purified gums was also determined by the British Pharmacopoeia method. Toxicity of the purified gums was evaluated using acute and sub chronic murine toxicity models. Quantities of elemental ions detected in both purified gums were not significantly high to affect the utilization of these gums as pharmaceutical excipients even in large dose and high dosing frequency drugs. Total aerobic viable counts of the gums were within the acceptable Pharmacopoeial specification and no harmful microorganisms were detected. Acute and sub-chronic toxicity tests of the gums showed that they are safe for use even in long term dosage regimen medications. Thus, when these gums are included in even long term use medicines as excipients, may not cause any harm to the patient. The gums are therefore safe and qualified for use as pharmaceutical excipients when purified.

Comparison of Monographs of Indian Pharmacopeia with BP and USP Pharmacopeia’s

The objective of this study is to emphasis on the importance of the chromatographic testing methods updates to evaluate the quality of drug products and drug substances. Indian pharmacopeial monographs compared with United States pharmacopeia and British pharmacopoeia monographs for the critical testing parameters. The monographs of most commonly prescribed or sold Tablets like Paracetamol, Amoxycillin, Co-amoxiclav, Losartan potassium and its drug substances were selected for this comparative study. The comparison was made to the critical tests like assay and related substances for drug substances; assay, dissolution and related substances tests for drug Products. It has been observed that the Indian pharmacopoeia assay and dissolution tests are comparable with other pharmacopoeias, however related substances methods of analysis need to be updated as per current requirement. The comparative study suggests that Indian Pharmacopoeia need to strengthen testing procedure and specification limits to improve the quality of pharmaceutical products.

The Effect of Acetylation of Faro 40 Rice Starch for the Production of Pharmaceutical Grade Starch

Introduction: Nigerian FARO 40 rice starch has been underutilized due to low edible qualities. Therefore, chemical modification of this variety for pharmaceutical use was contemplated, as native starch has shown to be integrally unsuitable for pharmaceutical applications. The aim of this study was to chemically modify underutilized rice variety using standard methods for possible use as pharmaceutical grade starch.&#x0D; Methodology: Native and acetylated FARO rice starch physicochemical properties were analysed using standard methods. Scan electron microscopy (SEM), Fourier transform infrared spectroscopy (FTIR), Thermogravimetric analyser and Derivative Thermogravimetric analyser were done to determine the morphological properties of native and acetylated starch. The starch tablets comparative binding and disintegrant capacities were examined utilizing paracetamol as model sedate. Wet granulation strategy and direct compression were used to defined the paracetamol tablets from native starch and acetylated starch as binders. The tablet features such as smashing quality, friability, crumbling time and disintegration test were assessed utilizing friabilitor machine, deterioration machine and disintegration device.&#x0D; Results: The results showed significant decreased (P&lt;0.05) values in pH, moisture content, and gelatinization temperature for acetylated starch compared to the native starch. Significant increase observed in ash content, solubility, swelling capacity, browning temperature, charring temperature and amylose content of acetylated starch as compared to the native starch. Furthermore, significant changes were also observed in morphology of the acetylated starch compared to the native rice starch. The weight, crushing strength, friability, disintegration time and dissolution profile values for paracetamol tablets formulated with the acetylated starch were within the standard specified by British pharmacopeia and were significantly different from that of native starch (P&lt;0.05).&#x0D; Conclusion: In conclusion, the research reviewed significant changes in physicochemical and morphological properties of acetylated FARO 40 underutilized Nigerian rice starch variety which suggest to improve the quality of the starch for pharmaceutical usage.

Review on Herbal Monograph Preparation

For instance, the British, Indian, and Japanese pharmacopoeias are manuals for the manufacture of high-quality medications that are released by a governing body or a concerned organisation. The therapeutic compendium and flavouring aggregation, however, are superior monographs on plant medicine (description of preparation on single topic). A compendium of knowledge is a pharmacopoeial work. on active pharmaceutical ingredients (API) or products (APP), including details on their solubility, impurity profiles, testing processes, and checks for contaminants. A book that discusses a botanical remedy and provides details essential for accurately recognising it may be referred to as a flavouring treatise. It provides the basic explanation, terminology, the amount used, and the ingredients, several application methods, contraindications, and an aspect. effects, medicine compatibility issues, dose, usage,, herb. For all individuals and organisations engaged in pharmaceutical analysis and development, manufacturing, and testing on a global scale, Aggregation is an essential resource. By developing standards of identity, purity, and analysis for botanicals as well as by reviewing both ancient and modern knowledge regarding their efficacy and safety, the flavouring association hopes to promote the responsible use of flavouring medicines with the highest possible degree of effectiveness and safety. The American Flavoring Association (AHP) and individuals from various nations (such as the United States Association, the European Association, the Association of the People's Republic of China, and the Indian Ayurvedic Pharmacopoeia) shall encourage the responsible use of flavouring the best feasible combination of safe and effective drugs, and to spread this knowledge. via means of monographs and other books. BP is currently used as a primary reference in more than 100 countries; the Yankee Flavoring Consortium (AHP) plans to offer 300 monographs on botanicals, including some of the Ayurvedic, Chinese, and Western herbs most frequently used in the USA; the Indian Flavoring Association (IHP) in its cover version covers 52 monographs on Indian meditative plants; and the African Flavoring Association (AHP) provides comprehensive and up to date botanic, commercial, and phytochemical information Many meditation plants employed in ancient Chinese culture have monographs in The People's Republic of China (PPRC, English ed. 2000). Some UN agency members don't have their own collection but instead adhere to one or more groups representing diverse states (e.g., in Australia, flavouring raw materials area unit needed to be attested to the relevant potential treatise within the British pharmacopoeia). The World Health Organization (WHO) has released 117 flavouring monographs since 1999 in four volumes, with the goal of promoting worldwide harmony in the internal management and use of flavouring medications as well as serving as templates for the creation of national formularies. in addition to a second volume (30 monographs, thirteen new and seventeen adopted from the present monographs). Each UN agency monograph contains a systematic description of facts regarding a small number of distinct medicinal plants or illicit substances on nineteen different themes, spanning from I Definition to (xvii) of different countries (e.g., in Australia, flavouring raw materials area unit needed to be attested to the relevant potential treatise within the British pharmacopoeia).Since 1999, 117 flavouring monographs have been released by the World Health Organization (WHO) in four volumes, along with 30 extra volumes that contain dosage forms, material medica, and references (xviii, xviii, xix). The flavouring aggregate consists of excellent and helpful botanical monographs. This comprehensive scientific reference list on the calibre, security, and efficacy of medicinal herbs is provided as a guide for flavouring discussions. The official compendia in the pharmacopoeia should not be considered to be a substitute for the UN agency monographs. Various plant parts, including as leaves, blossoms, fruit, seeds, stems, wood, bark, roots, rhizomes, ergot, shrubs, and flowers, are utilised as raw materials in organised medicine publications. In contrast, monographs on non-organic medicine list items like juices, gums, fixed oils, essential oils, latex, resins, fish liver oils, musk, beeswax, specific hormones, enzymes, and antitoxins in fresh or dry states, as well as other substances and blister beetles that can be whole, fragmented, or small-grained..

The Comparative Study of Different Pharmacopoeias: Indian Pharmacopoeia, British Pharmacopoeia, United States Pharmacopoeia

The objective of the study is to ensure Indian pharmacopoeia monographs are on par with United States, British pharmacopoeia standards. A few monographs were selected on random and compared. It has been observed that Indian pharmacopoeia has replaced titrimetrry assay method of analysis to sophisticated chromatographic techniques. As a whole the comparative study reveals that Indian pharmacopoeia is on par with United States, British pharmacopoeia and it is necessary that global countries also recognize Indian pharmacopoeia. General monographs available in Indian pharmacopeia 2014 were compiled and analyzed to identify the number of analytical method employed especially in the assays. HPLC Method of analysis is highest used where ever necessary UV method is made available instead especially for formulation, Indian pharmacopeia Commission is periodically updating indian Pharmacopoeia on par with ICH Q4 pharmaceutical harmonization and has its unique identity over years and being recognized globally.

Evaluation of sterilisation techniques for 3D-printed implantable devices

Abstract Objectives This article investigates the potential use of microwave (MW) radiation, ultraviolet (UV)-light and gamma radiation for the sterilisation of 3D-printed implantable devices prepared using poly(lactic acid) (PLA) and poly(vinyl alcohol) (PVA). Methods Samples were sterilised using MW, UV and gamma radiation. Subsequently, the sterility of these samples was tested following the British Pharmacopeia test for sterility and controlled contamination test. Finally, sterilised samples were characterised (DSC, FTIR and drug release studies) to evaluate potential changes in their physicochemical properties during sterilisation. Key findings MW-radiation failed the British Pharmacopeia test for sterility. UV-light did not pass the British Pharmacopoeia test for sterility, but it showed promising results for the controlled contamination test (bacterial-contamination reduction &amp;gt;99.9%). These techniques did not modify the physicochemical properties of PLA. On the other hand, samples treated with gamma radiation passed the British Pharmacopeia sterility tests. However, the Tg and mechanical properties of the resulting samples were affected by gamma radiation. It is important to note that none of the sterilisation methods investigated in this article resulted in any change in the in vitro release results. Conclusions Only gamma radiation passed the British Pharmacopeia test for sterility. However, the UV method showed potential and should be further investigated.

Study the Effect of Zwitterionic Hydrophilic Interaction for Simultaneous Determination of Non-Steroidal Anti-Inflammatory Drugs in Dosage Forms

Flurbiprofen and ketorolac are non-steroidal anti-inflammatory drugs (NSAIDs) that include both hydrophilic and hydrophobic functional groups in their structures. By connecting sulfobetaine molecules to polystyrene-divinylbenzene particles, two ZIC-HILIC stationary phases (ZIC-SB1 and ZIC-SB4) were developed for chromatographic separation of NSAIDs with varying chain lengths using Ultraviolet as detection. The different chain lengths of the stationary phases are utilized to investigate the retention behaviour of NSAIDs. Simultaneous quantification methods for ZIC-HILIC were developed. Flurbiprofen and ketorolac exhibited high precision with a small relative standard deviation (RSD) value of 0.48%, linear ranges of 0.015-6 and 0.06-4.5 ppm and detection limits of 0.009-0.006 and 0.01-0.008 ppm with a coefficient of determination (R2) of 0.9995-0.9997 for the ZIC-SB1 and ZIC-SB4 stationary phases, respectively. Statistical testing was used to compare the approaches to the British Pharmacopoeia protocol, and no difference in accuracy was discovered.

Evaluation of the Antioxidant and Wound Healing Properties of 80% Methanol Extract and Solvent Fractions of the Leaves of Vernonia auriculifera Hiern. (Asteraceae).

The leaves of Vernonia auriculifera (Asteraceae) have traditionally been used to treat wounds in several regions of Ethiopia. The purpose of this study was to assess the wound healing properties of the leaf extract and solvent fractions of V. auriculifera in mice. The leaf extract and solvent fractions of V. auriculifera have also been evaluated for their anti-oxidant properties because of their impact on the wound healing process. Air-dried leaves were extracted using 80% methanol. They were also successively fractionated with n-hexane, ethyl acetate, and methanol. The residue was then macerated in water for 72 hr. Simple ointment bases were formulated according to British Pharmacopoeia. Thereafter, two types of ointment formulations, 2.5% w/w and 5% w/w, were formulated. Wound healing and acute dermal toxicity studies were performed on mice. To assess free radical scavenging activity, a 2,2-diphenyl-2-picrylhydrazyl free radical (DPPH) assay was performed. In both models, wounds treated with 2.5% and 5% (w/w) of the ME, the aqueous fraction (AQF), methanol fraction (MEF), and ethyl acetate fraction (EAF) ointments demonstrated significant wound healing activity, as shown by enhanced wound contraction, a shortened epithelialization time, increased hydroxyproline content, and enhanced tissue breaking strength. The extract and solvent fractions displayed free radical scavenging activity with IC50 values of 1.2 mg/mL, 1.46 mg/mL, 1.5 mg/mL, and 2.83 mg/mL for ME, AQF, MEF, and EAF, respectively, as compared to 1.42 mg/mL for ascorbic acid. The result of this study indicates that 80% of methanol extract and solvent fractions are endowed with wound healing activity. Additionally, this study has also revealed that ME, AQF, MEF, and EAF have the capacity to scavenge free radicals. The study indicated that the wound healing effect could be attributed to the anti-inflammatory and antioxidant activities.

The Effect of Phosphorylation (Sodium Trimetaphosphate) of Faro 40 Rice Starch for the Production of Pharmaceutical Grade Starch

Introduction: Nigerian FARO 40 rice starch has been underutilized due to low edible qualities. The aim of this study was to chemically modify underutilized rice variety using standard methods for possible use as pharmaceutical grade starch.&#x0D; Methodology: The physicochemical properties of native and phosphorylated FARO 40 rice starch were analysed using standard methods. Scan electron microscopy (SEM), Fourier transform infrared spectroscopy (FTIR), Thermogravimetric analyser and Derivative Thermogravimetric analyser were utilized to decide the morphological properties of native and modified starch. The comparative binding and disintegrant capacities of these starch in tablets detailing were examined utilizing paracetamol as model sedate. Paracetamol tablets were defined using wet granulation strategy and direct compression utilizing native starch, acetylated starch, and phosphorylated starch as binders. The tablet features such as smashing quality, friability, crumbling time and disintegration test were assessed utilizing friabilitor machine, deterioration machine and disintegration device.&#x0D; Results: The results showed significant decreased (P&lt;0.05) values in pH, moisture content, and gelatinization temperature for modified starches compared to the native starch. Significant increase observed in ash content, solubility, swelling capacity, browning temperature, charring temperature and amylose content of phosphorylated starch as compared to the native starch. Furthermore, significant changes were also observed in morphology of the phosphorylated starch compared to the native rice starch. The weight, crushing strength, friability, disintegration time and dissolution profile values for paracetamol tablets formulated with the phosphorylated starch were within the standard specified by British pharmacopeia and were significantly different from that of native starch (P&lt;0.05).&#x0D; Conclusion: Chemical modification has shown to improve the physicochemical and morphological properties of the three FARO 40 underutilized Nigerian rice varieties for pharmaceutical purpose.

Synthesis, establishment of reference standard impurity A of ramipril and assessment of impurities in ramipril products

Ramipril, which is an angiotensin-converting enzyme (ACE) inhibitor, is prescribed to treat heart failure, diabetic kidney diseases and high blood pressure. The United States Pharmacopeia 43 (USP 43) and British Pharmacopoeia 2020 (BP 2020) require testing ramipril methyl ester (impurity A) in ramipril pharmaceutical substances as well as corresponding finished products. This study was conducted with the aim of synthesis and standardization of impurity A as related substance and using established reference impurity A in impurity test of ramipril pharmaceutical products. Impurity A was synthesized from ramipril by transesterification reaction with methanol and potassium hydroxide. The synthesized product chemical structure was elucidated from its spectroscopic data. High performance liquid chromatography (HPLC) method was utilized to determine its purity and establish it as reference standard. Finally, the assay of impurities in ramipril pharmaceuticals was determined by HPLC method, using the established impurity A standard. Ramipril methyl ester was successfully synthesized and purified with 39.2% yields (about 1.08 g). Impurity A purity determined was over 98% and conformed to establish reference standard. The assigned purity value of impurity A is 99.01%. Additionally, the assay of impurities in available ramipril pharmaceuticals by application of a HPLC method referred from USP 43 was conducted. Impurity A was successfully synthesized and standardized as reference standard for impurities test of ramipril.

Evaluation of modified Cenchrus americanus starch as disintegrant in formulation of chlorpheniramine maleate tablets

The aim of this research was to investigate the disintegrant properties of modified Cenchrus americanus starch (MCS) in chlorpheniramine maleate tablets formulation. The matured seeds of C. americanus were steeped in 4 L of 0.25 % w/v sodium hydroxide at 5 °C for 24h, washed, soaked in distilled water (30 ± 2 °C) for 24 h, and wet milled. The slurry was washed with distilled water through a 200 mesh screen, and the filtrate left undisturbed for 18 h. The top layer sediment was scrapped off, and the starch re-suspended with water. Further washing and sedimentation was done until the top layer of the starch became white. The starch was dried at 40 °C, defatted using Petroleum-Ether, air dried, sized (125µm) and characterized using standard methods. The MCS was used at 5, 10 and 15 % w/w as disintegrant in the formulation of chlorpheniramine maleate granules using the wet granulation method. Primogel at similar concentrations was used as comparing standard. Characterization of the granules for densities and flowability were done. Chlorpheniramine maleate tablets compressed from these granules were evaluated for uniformity of weight, hardness, disintegration time, assay and dissolution. Results showed poor flow properties for the MCS powder while the chlorpheniramine granules exhibited good flow. The tablets showed minimal variation in weight, good hardness (6.06±0.10 - 8.07±1.31 kgF), disintegration time (&lt; 7 min), friability (&lt; 1 %), and dissolution of more than 80 % within 30 min. The MCS compared favourably with primogel as disintegrant in chlorpheniramine tablets formulation and met with British Pharmacopoeia set limits.

Stability studies of reconstituted oral amoxicillin suspension (125mg/5ml) under different temperature storage conditions

The research objective was to determine the physical stability and concentration of amoxicillin reconstituted oral suspension (125mg/5ml) stored under room temperature of 25°C and refrigeration temperature of 2-8°C days 1, 3, and 7. Three different brands of amoxicillin samples were used. Samples from the reconstituted amoxicillin suspension was assayed by HPLC to determine the concentration of the active and examined physically for taste, odour and colour change. The drug concentration for all three brands during the seven days ranged from 88.94 per cent - 102.17 per cent for refrigerated and 89.57-99.7 per cent for reconstituted amoxicillin at room temperature. The odour for days 1, 3 and 7 is fruity. The colour was pale yellow for days 1 and 3, while on day 7, it was creamy yellow. The taste was sweet on days 1 and 3, while on day 7, it was sweet/low bitter. The three brands maintained their potency and physical stability as required in the British pharmacopoeia. The reconstituted antibiotic suspensions must be stored at room temperature or in a refrigerator to maintain potency throughout their use. However, a good number of patients do not adhere to storage specifications resulting in the degradation of the product and subsequent loss of potency. The results for day one for all the drugs fall within the accepted range, drug K has its percent concentration the lowest, and microbiological studies should be done on this drug to ascertain microbial stability.

In-vivo Wound Healing and Anti-Inflammatory Activity of the Solvent Fraction of Zehneria scabra L.F. Sond (Cucurbitaceae) Leaves.

Wounds continue to be a difficult clinical problem, with early and late consequences causing significant morbidity and death. As a result, proper wound management is critical. In addition to contemporary medicine, medicinal herbs serve an essential role in the treatment of wounds and bacterial infections. Z. scabra is a medicinal plant that has traditionally been used to treat wounds. However, there are no scientific reports on solvent fraction wound healing activities. As a result, the current study presents a scientific assessment of the wound healing ability of the solvent fractions of Z. scabra leaves. The leaves were crushed and macerated three times in 80% methanol. Chloroform, ethyl acetate, and aqueous fractions of simple ointment at 5% w/w and 10 percent w/w strengths were prepared using the fusion technique based on the British Pharmacopoeia. Excision and incision wound models were used to assess the solvent fractions' wound healing activities. The anti-inflammatory efficacy of crude and solvent fractions was tested in mice utilizing a carrageenan-induced hindpaw edema model. In rats, a test dose of 2000 mg/kg of the 10% w/w crude extract ointment was found to be safe. Groups treated with the 5% and 10% ethyl acetate fractions of the extract experienced significant (p<0.05 and p<0.01) wound reduction in the excision wound model. When compared to the negative control, the length of epithelization in groups treated with 10% ethyl acetate fraction and aqueous fractions of Z. scabra was statistically significant (p 0.001). By lowering the amount of carrageenan-induced paw edema, the leaf extract and the chloroform fraction of Z. scabra demonstrated a dose-dependent anti-inflammatory effect. The extract showed remarkable wound healing and anti-inflammatory activity and might be recommended for the treatment of many types of human wounds.

Empirical Quality Evaluation of Common Brands of Ceftriaxone Sodium Injection Marketed in the Northern Region of Nigeria

Information related to the quality of ceftriaxone (CF) sold in northern Nigeria is limited. Therefore, we aimed to evaluate the quality of different brands of CF sodium injections marketed in Kano State of Nigeria. Thirteen different brands of CF sodium for injection (three samples per brand) were obtained from patent medicines vendors (PMVs), pharmacies and a government drug store in Kano State of Nigeria. The quality of these brands was assessed using physicochemical quality-control tests (colour, appearance, labelling, pH, weight uniformity and percentage of content). The results obtained from these tests were checked for compliance with the standards specified in British Pharmacopoeia 2009 (BP 2009) and the United States Pharmacopeia 2016 (USP 2016). All 13 (100%) brands were registered with the National Agency for Food and Drug Administration and Control (NAFDAC). The samples were brands imported from other countries and passed tests for colour and pH. However, 1 of the 13 samples did not pass the labelling inspection and only 4 (30.8%) brands were found to fulfil the requirements for physical appearance. Twelve (92.3%) of the 13 evaluated brands were found to have an acceptable percentage of content within a range of 95%–105% based on BP 2009 standards. The tested brands of CF sodium injection being marketed in Kano State of Nigeria were found to have variable compliance regarding the BP 2009 and USP 2016 specifications. Therefore, there is a need for relevant regulatory agencies to embark on more post-marketing surveillance to ensure the quality of medicines in Nigeria.

Chemometrics integrated with in silico pharmacology to reveal antioxidative and anti-inflammatory markers of dandelion for its quality control

BackgroundDandelion is an herb with high nutritional and medicinal values, which has been listed in Chinese Pharmacopeia, European Pharmacopoeia and British Pharmacopoeia, gaining increasing acceptance around the world. However, the current quality control of dandelion is lagging behind. Only in Chinese Pharmacopeia, cichoric acid is used as a marker compound for its quality evaluation, whereas, it can not comprehensively reflect the bioactivity of dandelion.MethodsThis study developed a strategy by integrating chemometrics with in silico pharmacology to reveal the bioactive markers of dandelion for its quality control. Firstly, the major chemicals in dandelion were characterized using HPLC-DAD-MS/MS, and the corresponding antioxidant and anti-inflammatory activities were evaluated in vitro. Subsequently, the active components were screened by relating the chemicals and bioactivity of dandelion via grey relational assay and partial least squares regression analysis. The potential active components were then subjected to a validation for their activities. Moreover, in silico pharmacology was utilized to evaluate the contribution of active components to efficacy.ResultsA total of 22 phenolic compounds were characterized. Among them, cichoric acid, caffeic acid and luteolin were identified as quality markers owing to their good correlations with the bioactivities of dandelion. These three markers were quantified in frequently-used dandelion species, viz. Taraxacum mongolicum Hand.-Mazz. (TAM) and T. officinale F. H. Wigg. (TAO). TAM, with acceptably higher content of cichoric acid and caffeic acid, showed better antioxidant activity than TAO. While TAO included higher content of luteolin, presenting slightly more effective in anti-inflammation.ConclusionAn useful strategy for the quality marker discovery was successfully designed. And the results provided more knowledge for the quality evaluation of dandelion.

Diluent performance of a three component co-processed excipient for formulating ibuprofen tablets by wet granulation

Pharmaceutical tablets ingested orally remain the most popular dosage form in drug delivery, while the most frequently used route for administration of therapeutic agents remains the oral route. Recently, excipient development comprising a mixture of two or more materials assembled in a single frame by means of particle engineering, known as co-processed excipients, has gained enormous popularity. To prepare ibuprofen tablets by co-processing and wet granulation method and evaluate its diluent property. From the design of experiment (DOE), the optimized composition was obtained and ibuprofen granules were prepared for the newly developed co-processed excipient (lactose, mucin and corn starch BP) and starlac®, cellactose® and lactose as standards. The granules were evaluated for their micromeritic properties and compressed into tablets. Evaluation of the ibuprofen tablets for their physical properties and dissolution studies were done using British Pharmacopoeia methods. The results obtained showed that ibuprofen granules were flowable and compressible. The compressed ibuprofen tablets had good physical properties: minimal weight variation (495±9.46 – 501mg ±23.15), hardness (5.50 ±0.55 – 6.50±1.05 KgF), disintegration “time” &lt; 15 min±0.37 and “friability” &lt; 1.0 % ±0.00 - &gt;1.0±0.07. The dissolution of ibuprofen tablets complied with British Pharmacopoeia criteria. The data obtained from the different evaluation parameters containing the co-processed excipient compared well with starlac, cellactose and lactose used as comparing standard. The co-processed excipient which performed better than starlac in terms of friability and lactose in terms of disintegration can serve as a good diluent in ibuprofen tablets.