Innovare Academic Sciences: E-Journals
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GASTRO-RETENTIVE SUSTAINED RELEASE MUPS (MULTI-UNIT PARTICULATE SYSTEM) OF RIVAROXABAN FOR ORAL ADMINISTRATION
No full textObjective: This study focuses on the development and evaluation of gastro-retentive multi-unit particulate systems (MUPS) by utilizing fluidized bed coater, for the oral delivery of rivaroxaban, a direct oral anticoagulant (DOAC).
Methods: The method involves coating of three layers comprising the drug layer, effervescent layer, and polymer layer, each layer containing specific ingredients. These solutions were magnetically stirred, filtered, and coated onto sugar spheres (sucrose) using a Fluidized bed coater (FBC) (P+AM Glatt). The coated pellets were evaluated for parameters like particle size, friability, buoyancy, in vitro drug release, differential scanning calorimetry (DSC) analysis, scanning electron microscopy (SEM), and capsule filling performance. The method is designed in order to optimize the coating process and to assess the quality of pellets and enhance the drug delivery of rivaroxaban.
Results: Batch N-IV (4% Eudragit NM 30D) achieved 84.8% sustained drug release over 24 h with minimal burst (20.85% at 1 h), fitting the Korsmeyer-Peppas model (R²=0.995, n=0.647). This formulation floated rapidly (2.15 min lag time) for>24 h, and exhibited excellent physical properties (friability: less than 1%; Carr’s index: 0.842%; Hausner ratio: 1.008), with high drug loading (17.11 mg/250 mg pellets), and high coating efficiency (98.6%).
Conclusion: Compared to immediate-release formulations, the MUPS-based approach improved gastric retention, provide sustain release and improve dissolution profile along with a reduction in dosing frequency
ANTICANCER POTENTIAL OF ULTRASONICATED NANOEMULSION OF NIGELLA SATIVA OIL WITH PHYSICOCHEMICAL CHARACTERIZATION AND CYTOTOXICITY EVALUATION IN MCF-7 BREAST CANCER CELLS
No full textObjective: The objective of this study was to develop an ultrasonicated nanoemulsion of Nigella sativa (NS) oil and evaluate its anticancer potential through physicochemical characterization and cytotoxicity assessment in MCF-7 breast cancer (BC) cells.
Methods: The nanoemulsion was made utilizing Tween (Tw) 80 and investigated by particle size (PS), zeta potential (ZP), and thermodynamic stability. These parameters were evaluated by assessing physicochemical properties, antioxidant capacity through the DPPH assay, and cytotoxic potential by means of the MTT assay on MCF-7 BC cells.
Results: The finalized batch had a feasible droplet size of 47.09 nm, acceptable stability, and a proficient release profile of the drug in a long-term model (93.74% cumulative release). While nanoemulsion resulted in comparatively lower antioxidant activity than pure NS oil due to encapsulation and demonstrated a significantly lower IC₅₀ (1.435±0.148 µl/ml) than paclitaxel (5.317±0.112 µl/ml), and showed enhanced cellular uptake, as confirmed through FITC fluorescence imaging.
Conclusion: The finalized NS oil nanoemulsion demonstrated potent in vitro cytotoxicity against MCF-7 cells. However, further ex-vivo and in vivo investigations are required to confirm its suitability for topical BC therapy
QBD-GUIDED DESIGN OF NLC-BASED BUCCAL FILMS OF A PHYTOCONSTITUENT FOR ENHANCED CHEMOPREVENTION
No full textObjective: This study aimed to develop and optimize a nanostructured lipid carrier (NLC)-based hybrid buccal film of quercetin (QCT) using a Quality by Design (QbD) approach for potential chemoprevention of oral cancer.
Methods: QCT-loaded NLCs were prepared via the solvent injection technique using pre-screened excipients. A Design of Experiments (DoE) framework using the Box-Behnken Design was employed to assess the influence of total lipid content, surfactant concentration, and liquid lipid proportion on critical quality attributes—namely, particle size and drug entrapment efficiency. Transmission electron microscopy (TEM) was used to analyze morphology. Bilayer hybrid buccal films were cast using ethyl cellulose as the backing layer and a blend of hydroxypropyl methylcellulose and Carbopol 934P for the drug-loaded matrix. These films were evaluated for mechanical strength, in vitro drug release, ex vivo buccal permeation, stability, and cytotoxicity using cell line studies.
Results: QCT-NLCs were successfully formulated with glyceryl monostearate (solid lipid), Transcutol HP and Capmul MCM (liquid lipids), and surfactants including soya lecithin and Poloxamer 188. DoE analysis indicated that higher surfactant levels reduced particle size, while increased lipid content enlarged particles but improved entrapment efficiency. The optimized formulation had particle size of 144 nm and an entrapment efficiency of 90.21%, as verified by TEM. The resultant hybrid film demonstrated sustained drug release (80% over 8 h), excellent tensile strength (3.93 MPa), and was stable under accelerated conditions. Ex vivo studies confirmed 72.8% buccal drug permeation in 6 h. Cytotoxicity assays validated the formulation’s safety and chemopreventive potential.
Conclusion: The QCT-loaded NLC hybrid buccal film demonstrated potential as a safe and effective strategy for oral cancer chemoprevention
INNOVATION OF GREEN ESSENTIAL OIL NANOEMULSION (EO-NES) COMBINING NUTMEG (MYRISTICAFRAGRANS) AND GINGERGRASS (CYMBOPOGONMARTINIIVAR. SOFIA): POTENTIAL AS A HALAL COSMETIC PRESERVATIVE
No full textObjective: Nutmeg (Myristica fragrans) and gingergrass (Cymbopogon martinii var. sofia) essential oils in nanoemulsions promising antimicrobial and antioxidant activities. This study aimed to optimize the formulation of essential oil nanoemulsions (EO-NEs) combining Nutmeg and gingergrass using the Simplex Lattice Design (SLD) and antimicrobial effectiveness as a halal cosmetic preservative.
Methods: The nanoemulsions were prepared using a high-energy homogenization method with Tween 80 as the surfactant. Optimization was conducted using SLD to determine the optimal combination of essential oils and surfactant. Physical characterizations, including particle size, viscosity, pH, and stability, were performed. Antimicrobial activity was assessed using the disc diffusion method against bacteria and fungi.
Results: The optimized EO-NEs showed that the ratio of 0.591% Nutmeg and 9.409% ginger grass is the optimum mixture that produces physical properties of viscosity 9.39; pH 3.95; particle size 89.44; zeta potential-10.95; transmittance 88.04 with good stability and a desirability value of 0.915. Thermal cycle stability testing showed only minor changes in physical properties. Antimicrobial evaluation revealed that the EO-NEs demonstrated significant inhibitory effects, withno bacterial growth<10 CFU/ml for 28 days, excellent microbial reduction with a reduction of at least 99.0% (2 log) on day 2 and 99.9% (3 log) on day 7, and excellent microbial reduction with a reduction of at least 99.0% (2 log) on day 2 and 99.9% (3 log) on day 7.
Conclusion: The nutmeg and gingergrass EO-Nes formulated using the SLD method showed good physical stability and significant antimicrobial activity, indicating its potential as an effective natural preservative for halal cosmetic products
IN VITRO PREDICTION OF DRUG RELEASE PROFILE OF RIFAMPICIN IN CROHN’S DISEASE AND CHOLESTASIS DISEASE CONDITIONS USING BIOPHARMACEUTICAL TOOLS AND BIORELEVANT MEDIA
No full textObjective: Altered gastrointestinal physiology in Crohn’s disease and cholestasis may affect the intraluminal environment and impact the dissolution of orally administered drugs. Rifampicin exhibits pH and bile salt–dependent solubility, making it susceptible to variations in gastrointestinal conditions. The present research investigates in vitro dissolution behaviour of rifampicin in biorelevant media that simulate both healthy and disease-specific gastrointestinal environments.
Methods: Biorelevant dissolution medium that mimic the fasted-state intestinal conditions for healthy people, Crohn’s disease, and cholestasis were created by modifying pH, bile salt concentration, and the levels of mucin and inflammatory cytokines based on reported physiological values. Rifampicin fast-dissolving tablets (100 mg) were tested using United States Pharmacopeia (USP) Apparatus II (900 mL, 37 °C ± 0.5 °C) and spectrophotometric analysis. Dissolution profiles were analyzed descriptively.
Results: Rifampicin demonstrated slower drug release in Crohn’s disease–simulated medium (FaSSIF-CD) compared with FaSSIF-NA ( healthy condition). Drug release at 60 minutes exceeded 90% in FaSSIF control, whereas in FaSSIF-CD, it was limited to approximately 58–62% (p < 0.05). Conversely, dissolution in the cholestasis medium exhibited no significant divergence from the FaSSIF-NA under the evaluated conditions. The data demonstrate significant diversity in dissolution behaviour among media that simulate both healthy and disease-altered gastrointestinal environments.
Conclusion: These findings support the idea that physiological characteristics of the gastrointestinal environment may affect how rifampicin dissolves, as well as highlight the importance of media composition in predicting oral bioavailability in pathological states. Additional research with adequate clinical data is needed to go deeper into these findings and examine the molecular impacts on specific components
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR THE ESTIMATION OF ACTIVE INGREDIENTS IN XTEE HB TABLETS
No full textObjective: To develop and validate robust analytical methods for the quantification of ferric pyrophosphate (FPP), ascorbic acid (vitamin C), cyanocobalamin (vitamin B12), and folic acid (FA) in XteeHb tablets, addressing the analytical challenges posed by their diverse physicochemical properties.
Methods: Separate reversed-phase high-performance liquid chromatography (HPLC) methods were optimized and validated for ascorbic acid (vitamin C), cyanocobalamin (vitamin B12), and folic acid (FA), while ferric pyrophosphate (FPP) was quantified using a validated ultraviolet–visible (UV–Vis) spectrophotometric assay due to its inorganic nature and poor chromatographic response. Validation was performed in accordance with ICH Q2(R1) guidelines, assessing specificity, linearity, precision, accuracy, robustness, and forced degradation.
Results: All methods demonstrated excellent linearity (R² ≥ 0.999), precision (% RSD<2 %), and recovery values within 98–102 %. System suitability parameters met acceptance criteria for all analytes. Assay testing of marketed XteeHb Tablets showed compliance with specification limits (≥ 90 % of label claim), with no interference from excipients. The ultraviolet–visible (UV–Vis) method showed stable and reproducible absorbance for iron detection at 540 nm.
Conclusion: The validated analytical approaches are accurate, precise, and suitable for routine quality control, batch release, and stability monitoring of multicomponent hematinic formulations. This multi-method strategy provides a reliable framework to ensure the pharmaceutical quality of XteeHb Tablets and similar iron–vitamin supplements
GELATIN FROM MUSCOVY DUCK (CAIRINA MOSCHATA) BONE AS PHARMACEUTICAL EXCIPIENT: EXTRACTION AND CHARACTERIZATION
No full textObjective: This study aimed to extract and characterize gelatin from Muscovy duck (Cairina moschata) bone using acid method.
Methods: Gelatin production was carried out by soaking bone in 5 % hydrochloric acid with soaking times varying between 6, 12, and 24 h. The extraction process was conducted using a water bath at 70 °C for 4 h. Gelatin evaluation included yield value, proximate analysis (water content, ash content, lipid content, and total protein content), pH, viscosity, gel strength, color test, metal contamination level, fourier transform infrared (FTIR) and x-ray diffraction (XRD) analysis.
Results: The yield value of gelatin produced from Muscovy duck (Cairina moschata) bone was between 10.27-10.56 %, with water, ash, lipid, and total protein content of 2.26-3.14 %, 0.84-1.52 %, 0.24-1.15 %, and 71.05-75.86 %, respectively. PH of gelatin was 4.2-4.9, with a viscosity of 6.18-7.47 mPa. s, gel strength value was between 69.88-72.63 bloom, and color characteristic (L*= 33.33-35.31; a*= 0.52-0.81; b*=-0.55-0.26). In addition, the metal contamination levels were Cu<2 ppm, Zn<40 ppm, and As<0.2 ppm. FTIR profile showed that gelatin exhibited characteristic functional groups, while XRD analysis revealed that the diffraction peaks at 8° and 20° were specific characteristics of gelatin and similar to the commercial gelatin.
Conclusion: Gelatin produced from Muscovy duck bone has a good physical and chemical characterization and has FTIR profile and XRD profile similar to commercial gelatin, making it highly potential to be developed as an alternative source for gelatin production
PRESCRIPTION AUDIT OF GENERAL OPD AT A TERTIARY CARE HOSPITAL IN WEST BENGAL: CROSS-SECTIONAL STUDY
No full textObjective: Rational prescription practices are essential for effective healthcare delivery, ensuring optimal therapeutic outcomes and minimizing adverse effects and healthcare costs. Prescription audits are important tools to evaluate and improve prescribing behavior, especially in public health institutions in developing countries like India.
Methods: A cross-sectional observational study was conducted at the General Outpatient Department (OPD) of Barasat Government Medical College and Hospital (BGMCH), West Bengal, from December 2024 to February 2025. A total of 274 prescriptions were analyzed using the World Health Organization (WHO) core prescribing indicators. Parameters assessed included prescription completeness, drug details, use of generics, fixed-drug combinations (FDCs), antibiotics, injections, and essential drug list compliance.
Results: All prescriptions included patient and prescriber identifiers. The average number of drugs per prescription was 3.39. Generic drugs were prescribed in 44.53% of prescriptions, while branded drugs appeared in 347 instances. Antibiotics constituted 11.4% of drugs, and injections 1.3%. About 65% of prescribed drugs were from the National List of Essential Medicines (NLEM) 2022. Only 31.39% of prescriptions included patient instructions, and no prescriptions were written in the local language.
Conclusion: The audit revealed satisfactory practices in antibiotic use and essential medicine prescribing. However, improvements are needed in diagnosis documentation, generic prescribing, and patient communication. Regular audits, standardized templates, and prescriber training are recommended to ensure rational and patient-centered prescription practices
PRELIMINARY PHARMACOLOGICAL SCREENING OF MICROCOCCA MERCURIALI (L.) BENTH. LEAVES EXTRACTS FOR WOUND HEALING ACTIVITY
No full textObjective: Wound healing is a complex physiological process that requires a series of steps, each with several factors to come to completion. The objective of present study was to screen different extracts of Micrococca mercurialis (L.) Benth. leaves for wound healing activity using incision and excision wound model in experimental animals.
Methods: Different extracts of Micrococca mercurialis leaves were obtained by extraction with petroleum ether, chloroform, acetone, ethyl acetate, methanol and water. All these extracts were tested for detection of phytochemical constituents using different chemical test qualitatively. Preliminary wound healing activity was tested using incision and excision wound models and observed tensile strength of wound tissue in incision wound model. Wound contraction and biochemical estimation from wound tissue were observed in excision wound model.
Results: Results of present study was confirmed that methanol extract of Micrococca mercurialis leaves was showed higher tensile strength significantly (P<0.05) in comparison to the control group of animals. Hydroxyproline content and protein content were found significant (P<0.05) greater than the other extracts and standard marketed formulation (Povidone-Iodine ointment).
Conclusion: In conclusion, the potent wound healing effect of Micrococca mercurialis leaves extract may be attributed by the presence of phenolic and flavonoids components in the extract. Further detail study is required to explore the mechanism behind the healing effect and specific component responsible for activity
NEBULIZED BUDESONIDE AS ADD-ON TO STANDARD THERAPY IN CHILDREN AGED 5-14 YEARS WITH ACUTE EXACERBATION OF ASTHMA
No full textObjective: Out of the top 20 chronic conditions for global ranking of disability adjusted life years in children, asthma is one of them and specifically in the mid-childhood ages i. e, 5–14 y it ranks amongst the top 10 diseases, so we planned this study to see the efficacy of nebulized budesonide as add-on to standard therapy in children aged 5-14 y with acute exacerbation of asthma.
Methods: This was a prospective, randomized, open labelled, interventional study conducted in 5-14 y old patients of moderate to severe asthma having acute exacerbation. Thirty children with acute exacerbation of asthma presenting in the Paediatric department at PGIMS, Rohtak were randomized and assessed for efficacy according to PRAM score.
Results: PRAM Score at various follow-up time intervals was recorded in both groups and it was observed that mean±SD of PRAM Score at baseline, at 30 min, at 60 min and at 180 min showed non-significant difference during inter-group comparison. At discharge PRAM score was 0.39±0.50 and 0.32±0.48 in group I and group II respectively.
Conclusion: This study showed that both nebulized budesonide as an add-on and standard therapy in children aged 5-14 y with acute exacerbation of asthma showed significant improvement in respiratory status in terms of relief of respiratory symptoms with good safety profile and greater satisfaction with nebulized