VOLUME 13, ISSUE 01
Formulation and Evaluation of Sublingual Films of Lumateperone Tosylate
Manthan Ankoliya*, Nishith K Patel , Akash Vaghela , Zalak A Patel
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Review On HER2 Positive Breast Cance
Divya R Mahyavanshi *, Poornima S Gudeballur , Arindam Paul, Chirag Desai, Ankit Merai
Formulation and Evaluation of Rivaroxaban-Loaded Sustained Release Nanosponges
Akash B. Modi*, Priyanka Patel, Nishith K Patel
Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Lobeglitazone Sulphate and
Dapagliflozin Propanediol Monohydrate in Synthetic Mixture
Jinal Prajapati *, Nachiket Pandya , Vanita Marvaniya, Ketan Rathod
ABSTRACT:
Human epidermal growth factor receptor 2 (HER2) is a tyrosine kinase receptor that belongs to the epidermal growth factor
receptor family. Dimerization of the receptor causes auto phosphorylation of tyrosine residues in the receptor cytoplasmic
domain, triggering a range of signaling cascades that lead to cell proliferation and cancer. HER2 amplification or overexpression
is found in 15–30% of breast cancers and 10–30% of gastric/gastro esophageal tumour, and it is used as a prognostic and
predictive biomarker. Other malignancies with HER2 overexpression include the ovary, endometrial, bladder, lung, colon, and
head and neck. The introduction of HER2 focused medicines has a significant impact on the outcomes of patients with HER2
positive breast and gastric/gastro esophageal cancers; however, the results in other HER2 overexpressing tumour have been
dismal. This study examines the significance of HER2 in various malignancies and the therapy options for HER2
KEYWORDS: HER2, cancer, HER2 probes, Human epidermal growth factor receptor
![[x]](issue1_htm_files/close.png "Close")
ABSTRACT:
The formulation of sublingual films of Lumateperone Tosylate a second-generation antipsychotic that works by modulating dopamine,
serotonin, and glutamate neurotransmitters, was carried out in current research work. The prepared formulation evaluated through nine trial
batches, with various parameters assessed for performance. The key components of the formulation included three types of film-forming
polymers: Pullulan, HPMC E5 LV, and Lycagel, along with three types of plasticizers to improve flexibility and elasticity. Sucralose was used
as a sweetener to enhance the taste. Additionally, a drug release study revealed that Lycagel batches demonstrated faster drug release
compared to HPMC E5 LV and Pullulan, with over 90% of the drug released within 20 minutes. The T9 batch showed the highest drug
release, achieving 95% in just 15 minutes. In conclusion, the T9 batch was considered the most promising formulation due to its
combination of Lycagel as the film former, glycerin as the plasticizer, and its rapid disintegration and drug release characteristics. Further
studies, including Design of Experiments (DoE), was conducted to optimize the formulation.
KEYWORDS:Lumateperone Tosylate, Lycagel, sublingual films, antipsychotic
ABSTRACT:
An accurate, precise and robust stability indicating RP-HPLC method has been developed for the estimation of
Lobeglitazone sulphate and Dapagliflozin propanediol monohydrate in synthetic mixture. The chromatographic
separation of the drug and its Degradants was done by using a Inert sustain C18 column (250 mm × 4.6 mm, 5 μ) and
column oven set at 25 °C with a mobile phase consisting of methanol : phosphate buffer (pH 3.5) in 65:35%v/v ratio at
a flow rate of 1.0 mL/min and an injection volume of 50 μL. Force degradation studies of samples and standard were
conducted under alkaline, acidic, oxidative, thermal, and Photo degradation conditions, with analysis performed using
the proposed method. The method exhibited the well separation of the degradation peaks from Analyte peaks,
indicative of stability indicating nature of the method. The developed method was then validated in accordance with
ICH guidelines for specificity, precision, linearity and range, limit of quantification, limit of detection, assay, and
robustness, ensuring reliability and accuracy..
KEYWORDS: Lobeglitazone sulphate, Dapagliflozin propanediol monohydrate, RP-HPLC method, forced
degradation, validation, stability-indicating
ABSTRACT:
This study reports the successful formulation of Rivaroxaban-loaded sustained-release nanosponges via the emulsion solvent evaporation method
using ethyl cellulose as the polymer matrix, polyvinyl alcohol (PVA) as stabilizer, and glutaraldehyde as crosslinker. Ten formulations (F1–F10) were
screened to optimize polymer concentrations, with the best batch showing 82.3% drug entrapment efficiency, a particle size of 247.50 nm, zeta
potential of –33.4 mV, PDI of 0.249, and an 86.5% yield. In vitro release studies revealed90.0% drug release over 24 hours, indicating effective
sustained delivery. XRD confirmed reduced crystallinity of Rivaroxaban in the matrix, while TEM images showed uniform spherical nanosponges.
Short-term stability at 40 ± 2°C / 75 ± 5% RH for 30 days showed minimal changes in entrapment efficiency and drug release, confirming formulation
stability. These findings suggest that nanosponge-based delivery of Rivaroxaban offers a promising sustained-release platform to enhance patient
compliance and therapeutic efficacy.
KEYWORDS: Rivaroxaban, Sustained Release, Nanosponges, Ethyl Cellulose, PVA, Entrapment Efficiency, Particle Size, Drug Release.
