Journal of Applied Pharmaceutical Research (JOAPR)
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Formulation and evaluation of mucoadhesive microspheres of metronidazole
Get PDFObjective: Develop and evaluate mucoadhesive microspheres using Chitosan, Sodium alginate, and Sodium carboxymethyl cellulose (NaCMC) for sustained oral delivery of Metronidazole, aiming to improve bioavailability. Methods: Metronidazole-loaded microspheres were prepared via ionotropic gelation method with varying polymer ratios. Particle size, entrapment efficiency, swelling index, mucoadhesion (sheep mucosae), morphology (SEM), in-vitro wash-off test, drug release profile, and stability (6 months) were evaluated. Results: Chitosan content positively correlated with microsphere size. Entrapment efficiency ranged from 51.43% to 94.15%. Chitosan-based formulations, especially MTZ-7 (Chitosan:NaCMC, 3:1), displayed the highest mucoadhesion. SEM analysis revealed rough, spherical microspheres with a continuous polymeric coat. In-vitro wash-off test demonstrated prolonged residence time for Chitosan formulations. Sustained drug release was observed throughout the study, with MTZ-7 exhibiting the most desirable release profile. Stability studies showed no significant changes in drug release for selected formulations after 6 months. Conclusions: Chitosan-based microspheres, particularly MTZ-7, demonstrated superior mucoadhesive properties, sustained and controlled drug release, and desirable stability. These findings suggest the potential of Chitosan-based microspheres as a promising oral drug delivery system for Metronidazole, potentially addressing bioavailability concerns and improving therapeutic efficacy
Safety study of carboxymethylated Basella alba mucilage: a subchronic oral toxicity evaluation in Wistar albino rats
Get PDFBackground: The evaluation of toxicity is of paramount importance in the screening of a new compound. Basella alba mucilage possesses a versatile excipient property that can be innovated with its chemical modification to get the functionalized mucilage. A few pharmacological activities of Basella alba mucilage have also been reported earlier, but its toxicity study in rats has yet to be discussed. Aim: The study aims to assess the in vivo toxicity of carboxymethylated Basella alba mucilage in Wistar albino rats for 28 days. Material and Methods: In the current investigation, Carboxymethylated Basella alba mucilage is taken, and its subchronic toxicity study is carried out in forty-eight healthy rats (twenty-four male rats and 24 female rats), divided into four groups containing six rats of each sex. All the biochemical and hematological parameters and histopathological investigation were estimated for all the animal groups. Result: The subchronic toxicity study reveals that the modified mucilage is safe for all doses (20mg/kg body weight, 40mg/kg body weight, 80 mg/kg body weight). The study showed no significant difference in the dose group's behavioral toxicity, nephrotoxicity, and hepatotoxicity compared to the control. All the hematological and biochemical parameters lay in the normal range. The histopathological examination of treatment groups showed no abnormality or lesion in the tissue samples of internal organs. Conclusion: The study confirms the safety of Carboxymethylated Basella alba mucilage for use in pharmaceutical formulations
Innovative and cost-effective SesZen-Bio™ with enriched Biotin and improved superior dissolution efficiency
Get PDFBackground: Micronutrient deficiencies, including biotin, iron, zinc, and vitamin D, can lead to hair problems such as loss and thinning. This study explores the improvement of SesZen-BioTM, a natural biotin supplement derived from Sesbania grandiflora leaves, to give NI- SesZen-BioTM. Materials: The nature and structure of biotin in SesZen-BioTM were evaluated using C14 analysis and 1H NMR. Further, Sesbania grandiflora was subjected to an improved economic process to give NI-SesZen-BioTM. HPLTC-aided phytochemical profiling was performed for SesZen-BioTM, NI- SesZen-BioTM, and standard S. grandiflora leaf extract. The purity of d-biotin was quantified using HPLC. The dissolution profile of SesZen-BioTM and NI- SesZen-BioTM was tested to determine bioequivalence and compared versus synthetic biotin. Results: NMR and C14 analysis revealed that SesZen-BioTM contained 100% natural d-biotin. The yield for SesZen-BioTM and NI- SesZen-BioTM was found to be 17% and 18%, respectively, and both exhibited phytochemical profiles similar to standard extract. The release rate for SesZen-BioTM was similar till a dose of 500 mg and slowly decreased at higher concentrations (800-100mg). A 350 mg NI- SesZen-BioTM showed bioequivalence to 250 mg and 500 mg for SesZen-BioTM. Percent d-biotin content was 0.5% in SesZen-BioTM and 0.81% in NI- SesZen-BioTM. Conclusion: This new economically driven process yielded NI-SesZen-BioTM, with similar yield, higher biotin (100%natural) content, and similar dissolution profile but at a reduced dosage as compared to SesZen-BioTM and surpassed synthetic biotin with its sustained release format. Thus, NI- SesZen-BioTM is a promising solution for individuals seeking natural supplements for maintaining hair and skin heath
LC-MS/MS characterization of stress degradation products of Gilteritinib and establishment of HPLC method for analysis of process related impurities of Gilteritinib
Get PDFBackground: The current investigation entails the characterization of seven degradation products (DPs) formed in different stress conditions of gilteritinib employing liquid chromatography-tandem mass spectrometry (LC-MS/MS). Methodology: This study developed a stability-indicating reversed-phase high-performance liquid chromatographic (HPLC) method for precisely determining gilteritinib in the presence of its process-related impurities in bulk drug and formulation samples. To explore the stability profile of gilteritinib, it was exposed to forced degradation experiments conducted under various conditions, including acidic, basic, oxidative, photolytic, and thermal stress. These experiments revealed the degradation of gilteritinib under basic, acidic, and photolytic conditions, forming seven distinct DPs. Result: The chromatographic resolution of gilteritinib and its impurities along with DPs was effectively achieved using a Waters Symmetry C18 (250 mm × 4.6 mm, 5 μm) column using equal volumes of solvent A and B (pH 4.5 phosphate buffer and acetonitrile in 25:75 (v/v) as solvent A, acetonitrile and methanol in 75: 25 (v/v) as solvent B) pumped isocratically at 0.7 mL/min and 230 nm wavelength. The method produces an accurate fit calibration curve in 25-175 μg/mL for gilteritinib and LOQ (0.025 μg/mL) – 0.175 μg/mL for its impurities with acceptable precision, accuracy, and recovery. Conclusion: The efficacy of this method was validated through LC-MS/MS, which allowed for the verification of the chemical structures of newly generated degradation products of gilteritinib. Hence, this method is appropriate for the resolution and evaluation of process-related impurities of gilteritinib and can also be applied for evaluating stress degradation products
Correlational study of Vitamin-D deficiency levels and its severity of community-acquired pneumonia in patients admitted into a tertiary care hospital
Get PDFBackground: Recent studies have emphasized that people who have low levels of Vitamin D are more prone to the development of infectious diseases, particularly of a community-acquired nature, which has differential morbidity and mortality. Aims & objectives: The present study aimed to determine the correlation between different levels of vitamin D deficiency and severity and outcomes in patients diagnosed with community-acquired pneumonia. Methods: In this study, the serum level of Vitamin D of 100 consecutively admitted community-acquired pneumonia patients was measured. Depending on the level of Vitamin D deficiency, patients diagnosed with community-acquired pneumonia (CAP) were assessed for severity of illness by CURB-65 score. Results & Discussion: In the study population, out of 100 patients, 82% of the study sample had deficient serum vitamin D levels. In the study sample, 41 patients with higher deficiency levels of serum Vitamin D have severe illness and scored high on CURB- 65, which is in the range of three to four on the scale. 59 patients with low deficiency levels of serum Vitamin D had low scores of one or two on the CURB-65. On severity assessment in patients with severe deficiency of Vitamin D, the mean length of hospital admission was 12.30±8.47 days compared to patients with mild deficiency of Vitamin D, where the average hospital stay was 8.58±4.04 days. Conclusion: As the severity of deficiency of Vitamin D increases, the frequency of CAP increases, and it is also observed that a severe degree of deficiency is associated with severe illness and prolonged hospital stay
Optimization and evaluation of nebivolol hydrochloride loaded transferosomes using Box-Behnken experimental design
Get PDFBackground: This study optimizes and evaluates transferosomes containing Nebivolol Hydrochloride to enhance the drug's bioavailability and therapeutic efficacy. Ultra-deformable vesicles called transferosomes help to increase drug administration via the skin. Methodology: Using a thin-film hydration technique, beta-blocker Nebivolol Hydrochloride, which has antihypertensive properties, was added to transferosomes. To attain the ideal vesicle size (between 200 to 300 nm), entrapment efficiency, and deformability, the formulation was adjusted by adjusting the amounts of phosphatidylcholine, Span 80, and hydration time using a Box-Behnken experimental design. Particle size analysis, zeta potential measurement, and in vitro drug release tests were performed to characterize the transferosomes. Results and discussion: The optimized formulation demonstrated notable deformability, an entrapment effectiveness of 50%, and a vesicle size of 265 nm. The Box-Behnken design made it easier to evaluate the interactions between variables systematically. In vitro drug release studies showed a drug diffusion that persisted for a whole day, suggesting that transferosomes may have long-lasting therapeutic effects. Stability studies at room temperature and accelerated conditions over six months confirmed the formulation's robustness. Conclusion: The results imply that Nebivolol Hydrochloride transferosome-based delivery may be a viable strategy for improving the drug's bioavailability and effectiveness, as nearly 100% of drugs diffuse within 24 hr, perhaps leading to a breakthrough in the management of hypertension
Investigating phytochemical diversity and antioxidant richness of Moringa oleifera in Tamil Nadu
Get PDFBackground: Moringa oleifera Lam., widely known as ‘The Tree of Life’, is a medicinal tree native to India and extensively grown in tropical regions worldwide. In India, Tamil Nadu is the leading state, engaging an area of 20684 hectares in the production of moringa. In South India, moringa is extensively utilized as a vegetable for its exquisite taste and flavor in sambar and curry preparation. Methodology: Phytochemical analysis of leaves from the Tamil Nadu region and simultaneous estimation of quercetin, rutin, and gallic acid contents in moringa leaf extracts from the Tamil Nadu region via HPTLC analysis was carried out. DPPH assay was performed to determine the antioxidant potential. Results and Discussion: The hydroalcoholic extract obtained from the triple maceration of moringa leaves possesses high amounts of phytoconstituents such as flavonoids and polyphenols. Each gram of the extract contained 1650.401 µg of quercetin, 1136.950 µg of rutin, and 220.223 µg of gallic acid. The IC50 value of the extract was calculated to be 36.10 µg/ml. Conclusion: The extract from the leaves of the moringa plant grown in the Tamil Nadu region contains a good amount of phytoconstituents and also possesses good antioxidant activity comparable to that of standard ascorbic acid, suggesting its potential use as an antioxidant agent. The findings of the present study support the traditional use of the folklore plant for improving health
Effectiveness and usage of written and verbal counselling information on anxiety in MRI at a tertiary care hospital in Chennai
Get PDFBackground: Many people have considerable anxiety when having magnetic resonance imaging (MRI). Fear during an MRI causes the process to drag on longer and the quality of the images to decline, which increases expenses and requires labor loss. Objective: This study sought to determine how vocal and written information affected patients' anxiety during MRI procedures. Materials and Methods: A prospective cross-sectional study with 300 participants was conducted. The investigation occurred in March and April of 2022 at the tertiary care hospital's radiology department. Three participant groups were formed: group 1 received textual material, group 2 served as the control group, and so on; and group 3 learned about counseling. The State-Trait Anxiety Inventory (STAI), a measure of anxiety levels, was used to determine the people's traits and state of anxiety. Results: The three groups' trait anxiety scores did not significantly differ (p = 0.20) from each other's demographic features. Statistically speaking, group 3's state anxiety levels were lower than those of group 2 and the control group. Group 2's state anxiety levels were statistically lower (p<0.001) than those of the control group. Conclusion:Verbal and written information can help to lessen MRI anxiety. Written information may not be as good at lowering MRI anxiety as verbal information
Preparation of herbal hair oil exploring the therapeutic benefits of herbs and its evaluation
Get PDFBackground: Herbal cosmetics, particularly herbal hair oils, have gained popularity due to their perceived efficacy and minimal adverse effects. This study aimed to formulate and evaluate herbal hair oils for promoting hair growth. Methodology: Various herbal extracts, including Coconut, Curry leaves, Amla, Fenugreek, and Onion, were prepared and incorporated into virgin Coconut oil. Phytochemical screening, total flavonoid content, organoleptic evaluation, chemical analysis (acid value, saponification value, specific gravity), stability studies, antioxidant assay (DPPH), antimicrobial assay, sensitivity studies, and in-vivo hair growth activity were conducted. Results: Organoleptic evaluation revealed characteristic odors and colors across formulations. Chemical analysis showed acceptable values for acid value (0.68 - 1.86 mg KOH/g), saponification value (117.87 - 224.27 mg KOH/g), and specific gravity (0.865 - 0.933 g/cm^3). Stability studies over 45 days demonstrated consistent physicochemical properties. The DPPH assay indicated dose-dependent antioxidant activity, with inhibition ranging from 13.8% to 66.5%. Antimicrobial assay showed inhibition zones ranging from 6 mm to 20 mm against Staphylococcus aureus. Sensitivity studies exhibited no adverse reactions. In-vivo hair growth activity demonstrated significant improvements compared to controls. Discussion: The formulated herbal hair oils exhibited promising physicochemical properties, antioxidant activity, antimicrobial efficacy, safety, and hair growth promotion in animal models. These findings suggest their potential as natural remedies for hair care. Conclusion: Herbal hair oils formulated in this study show significant potential for promoting hair growth and addressing hair-related concerns. Whereas, formulation F3 shown significant efficacy across multiple parameters among the formulations. Further research and clinical trials are warranted to validate their efficacy and safety for human use
Stability indicating RP-HPLC method for estimation of cariprazine hydrochloride in human plasma
Get PDFObjective: The objective of the study is to create and validate the easy, dependable, accurate, sensitive, and selective RP-HPLC method for estimating Cariprazine HCl in human plasma. Methodology: The sample was prepared using the protein precipitation extraction method. The chromatographic separation was performed with an AGILENT C18 column (250mm x 4.6ID) as the stationary phase and a mobile phase consisting of a 75:25 v/v solution of Methanol and 0.1% Orthophosphoric acid at a flow rate of 0.7 ml/min. The DAD detector was used to carry out the detection at 253 nm. Cariprazine HCl had a reduced retention duration of 2.46 minutes. Results & Discussion: The calibration curve had a correlation coefficient of 0.998 and was linear over the concentration range of 1–5µg/ml. The method's accuracy was shown at levels between 80%, 100%, and 120% of the specification limit. The developed method exhibited excellent precision, with interday precision ranging from 0.07% to 1.77% and intraday precision from 0.03% to 0.26%. It was discovered that the recovery of Cariprazine HCl was within the 98% range. Cariprazine HCl was discovered to have a Limit of Detection (LOD) of 0.053µg/ml, and the Limit of Quantification was found to be 0.160µg/ml. Conclusion: The solution was injected in duplicate, and the % RSD was measured. The results indicate that the proposed method can be effectively utilized for the routine analysis of Cariprazine HCl in human plasma. The forced degradation studies indicate that the drug is susceptible to Hydrolytic and Photolytic degradatio