Electrostatic powder deposition as a dry powder process to prepare orodispersible films

Orodispersible films (ODFs) are an advantageous dosage form, particularly for pediatric and geriatric populations, due to their ease of administration. ODFs are predominantly manufactured by solvent casting using aqueous or organic solvents. However, this process may be limited by long drying times for aqueous systems, required solvent handling capabilities and residual solvent testing for organic solvents, or due to moisture or solvent sensitive active pharmaceutical ingredients (API). Additionally, solvent casting can produce non-uniform doses due to API aggregation in solution or during drying. More recently, electrostatic powder coating has been adapted as a dry powder process for coating pharmaceutical dosage forms, such as tablets and pellets. Electrostatic powder coating is advantageous as it eliminates the need for solvents and exhibits greater transfer efficiencies than non-electrostatic dry powder coating. In this work, this technology was further modified to utilize electrostatic powder deposition (ESPD) as a dry powder process to prepare ODFs. Low molecular weight polyethylene oxide (PEO) was investigated as the film-forming polymer for use with ESPD. The influence of processing parameters, such as charging voltage, curing conditions, and substrate roughness, on PEO deposition behavior and film formation were investigated. The deposition behavior of PEO was significantly influenced by the environmental humidity during processing due to its impact on the particle resistivity. The PEO films prepared by ESPD exhibited favorable mechanical properties, a low degree of adhesion to the substrate, and rapid disintegration. Drug-containing films were prepared using physical mixtures and composite particles of acetaminophen (APAP) and PEO. Films prepared using a physical mixture exhibited significantly higher drug content variability. The active films exhibited favorable mechanical properties due to the plasticizing effect of APAP on PEO. Additionally, the films exhibited rapid drug release in vitro, with greater than 85% drug release by two minutes. Films with increasing drug load were prepared using ESPD utilizing both physical mixtures and composite particles of benzocaine (BNZ) and PEO. Films prepared using physical mixtures were superpotent due to preferential deposition of the charged BNZ particles during ESPD. The complex viscosity profile of the composite particles were shown to decrease with increasing drug loading, enabling lower cure temperatures for film formation. Films produced using the composite particles exhibited low adhesion to the substrate and rapid in vitro drug release. However, the composite particles of the highest drug load showed greater crystalline BNZ content than the lower drug loads, resulting in a decrease in its mechanical properties, as well as a slightly reduced dissolution rate. Ultimately, this body of work demonstrated that ESPD could be utilized as a solvent-free process to prepare orodispersible films with favorable mechanical and drug release properties. Additionally, the use of composite particles has been shown to be advantageous to produce particles with favorable electrical properties, ensure film drug content uniformity, and enable reduced cure temperatures.Pharmaceutical Science

Study of molecular association in binary mixtures of poly(vinyl pyrrolidone) (PVP) with ethanol, 1-propanol and 1-butanol through thermo-acoustical, FT-IR, UV–Vis spectroscopy and DFT studies

In the present paper we report the variations of thermo-acoustical parameters along with FT-IR, UV–Vis analysis for the binary mixtures of PVP with ethanol, 1-propanol and 1-butanol with increasing concentrations. The thermo-acoustical parameters such as acoustic impedance (Z), surface tension ($$\sigma$$), relaxation time ($$\tau$$) and absorption coefficient ($$\alpha /{f}^{2})$$ have been computed. The variation in these parameters manifest increased intermolecular interactions between PVP and polar solvents (ethanol, 1-propanol and 1-butanol) with concentrations. The intermolecular interaction is well corroborated and quantified by theoretical calculations based on density functional theory. The intermolecular hydrogen-bond strength has also been computed using the theory of Atoms in Molecules for higher concentration of these binary mixtures. FT-IR and UV–Vis spectra have been recorded at higher concentration range (0.7%, 0.8%, 0.9%) in the wavenumber range (4000–500 $$\hbox {cm}^{-1})$$ and wavelength range (200–400 nm) respectively. The experimental FT-IR and UV–Vis spectra are also in good agreement with the calculated data as obtained by the DFT/B3LYP method

Risk Assessment of Type II Diabetes using Indian Diabetic Risk Score in Andhra Pradesh, India: A Cross-sectional Study

Introduction: Diabetes has emerged as a global pandemic of the 21st century, with approximately 463 million adults (aged 20- 79 years) living with diabetes worldwide in 2019. Type 2 Diabetes Mellitus (T2DM) is the most common form of diabetes compared to Type 1 and other forms. The burden of diabetes in India is expected to increase in the coming years. The Indian Diabetes Risk Score (IDRS) is a validated and cost-effective tool used to identify the risk of developing diabetes among the population. Aim: To estimate the risk of T2DM using the IDRS in adults aged 25 years and above. Additionally, the study aimed to explore the association between the risk of diabetes and other factors. Materials and Methods: An observational, community-based, cross-sectional study was conducted in the field practice area of Kurnool Medical College, Kurnool, Andhra Pradesh, India. Data collection took place from December 2022 to February 2023, using a simple random sampling technique. The study included residents aged over 25. A sample size of 100 participants was selected. The IDRS, developed by the Madras Diabetic Research Foundation (MDRF), was used as a validated tool to screen individuals at high-risk of developing T2DM. Data was collected using a semistructured questionnaire that included socio-demographic information, the IDRS tool to detect the risk of developing diabetes, and other risk factors such as Body Mass Index (BMI), family history of diabetes, physical activity, smoking, alcohol consumption, and hypertension. Data analysis was performed using the Statistical Package for Social Sciences (SPSS) version 23.0. The Chi-square test was used to determine significance, with a p-value of <0.05 considered significant. Results: A total of 100 residents aged over 25 years were included in the study. IDRS categorisation revealed that 14 (14%) were at low risk, 43 (43%) at moderate risk, and 43 (43%) at high-risk for developing T2DM, respectively. A statistically significant association was observed between diabetes risk score and individuals who smoked (p=0.04), consumed alcohol (p=0.04), and had hypertension (p<0.001). BMI showed a positive correlation with IDRS score (p=0.031), family history score (p=0.028), and waist circumference score (p=0.034). Conclusion: Early detection of the risk of diabetes through periodic screening and effective behavioural change communication could be instrumental in controlling the diabetes crisis