Emami (India)

Hydroxypropyl methylcellulose acetate succinate (HPMCAS) has multi-disciplinary applications spanning across the development of drug delivery systems, in 3D printing, and in tissue engineering, etc. HPMCAS helps in maintaining the drug in a super-saturated condition by inhibiting its precipitation, thereby increasing the rate and extent of dissolution in the aqueous media. HPMCAS has several distinctive characteristics, such as being amphiphilic in nature, having an ionization pH, and a succinyl and acetyl substitution ratio, all of which are beneficial while developing formulations. This review provides insights regarding the various types of formulations being developed using HPMCAS, including amorphous solid dispersion (ASD), amorphous nanoparticles, dry coating, and 3D printing, along with their applicability in drug delivery and biomedical fields. Furthermore, HPMCAS, compared with other carbohydrate polymers, shows several benefits in drug delivery, including proficiency in imparting stable ASD with a high dissolution rate, being easily processable, and enhancing bioavailability. The various commercially available formulations, regulatory considerations, and key patents containing the HPMCAS have been discussed in this review.

The global trade of medicinal plants and their derivatives was estimated at US$33 billion in 2014, and the World Health Organization has estimated that it will increase to US$50 trillion by 2050. Different regulatory frameworks and categories at the national and regional levels describe medicinal plants either as mainstream therapy or as complementary and alternative medicines. The resulting complex terminology has seen medicinal plants classified as medicines (Australia), herbal medical products (European Union), botanicals (United States), and natural health products (Canada). In China, there is a distinction between traditional Chinese medicine (TCMs) and natural medicinal products. In India, traditional medicine is separated into three systems: Ayurveda, Unani, and Siddha. In Japan, Kampo medicines are classified as pharmaceutical drugs, and in Thailand, as part of the primary health care system. Many national health authorities have established guidelines and regulations concerning the quality, efficacy, and safety profiles of these products. Five papers are included in this Research Topic, all of which concern these three fundamental aspects of the health properties of herbal medicines.

Background: Abiraterone acetate is a derivative of steroidal progesterone, used as a first-line therapy for metastatic castration of prostate cancer. Objective: The present study encompasses the design of an experiment approach for developing a simple, reliable, and rapid RP-HPLC method for the estimation of abiraterone acetate. Method: The chromatographic separation was efficiently conducted on a Hypersil Gold C18 (50 x 4.6 mm, 5 µm) HPLC column, using the mobile phase composition of acetonitrile: dibasic potassium phosphate (0.01 mM) in the ratio of 80:20 (%v/v) at pH 6.5 with an isocratic elution mode. Furthermore, the different force degradation study including hydrolysis, oxidation, thermal, and photolytic was performed for abiraterone acetate. Result: The dynamic linearity was established in the concentration range of 0.5-10 µg/mL with r2 of 0.9998. Furthermore, the limit of detection and the limit of quantitation were 0.0978 µg/mL and 0.3260 µg/mL. The degradation of abiraterone acetate was shown in both acidic (54.16 ± 0.247 after 24 hrs) and basic conditions (35.06 ± 0.458 after 24 hrs). Furthermore, the developed method was successfully employed to quantify abiraterone acetate in bulk powder and the solid dispersion did not show any change in the retention time. Conclusion: The developed method was validated according to the ICH Q2 (R1) specification, which was found to be sensitive, accurate, precise, robust, linear, and selective compared to the reported chromatographic method.

Trigonelline (TR), 4-hydroxyisoleucine (4-HI), and diosgenin (DG) are the main bioactives of the purified standardized extract of the popular plant Trigonella foenum-graecum L. (TFG), and it has been proven effective for the treatment of various diseases. However, to the best of our knowledge, no study has investigated the pharmacokinetic parameters of purified standardized T. foenum-graecum extract in normal and diabetic Wistar rats. The present study has developed and validated a rapid, reliable, and sensitive simultaneous ultra-performance liquid chromatography MS method to estimate these bioactives. The chromatographic separation was achieved using methanol, acetonitrile, and 0.1% formic acid with the ideal gradient flow system on a BEH Shield RP 18 column. A positive electrospray ionization mode was selected to estimate m/z values of TR (138.14 > 94.63), 4-HI (148.19 > 74.08), and DG (415.54 > 271.33). The method was robust and reproducible over the linearity range of 60-5000, 6-5000, and 15-5000 ng/mL for TR, 4-HI, and DG, respectively. Using this novel validated method, we investigated the pharmacokinetic parameters of bioactives using Phoenix WinNonlin version 8.0 (Certera) in normal and diabetic rats. The assay was successfully applied for the estimation of pharmacokinetic parameters using noncompartmental analysis. This investigation shows that the absorption rate increased, whereas distribution and elimination processes slowed down in diabetic rats compared with normal rats.

Background: This study aims to determine the applicability of genome-wide polygenic risk score (GPS CAD ) to patients who underwent off-pump (OP-CABG) in South-Asian population and influence, on kidney dysfunction and incidence of AKI in OP-CABG. Methods: Study participants were categorized into four cohorts: 1) patients with normal renal function undergoing OP-CABG (eGFR>60ml/min/m 2 ) (n=754; AKI - 81, Non-AKI-673); 2)patients with renal dysfunction (eGFR<60ml/min/m 2 ; not needing dialysis) undergoing OP-CABG (n=263; AKI-169, non-AKI-89); 3) patients with renal dysfunction with no symptomatic/known heart disease (n=92);4) control population (with normal kidney function, without symptomatic/known heart disease) (n=826). Genotyping was performed using Infinium Global Screening Array-24 v3.0 BeadChip from Illumina, which included 6,54,027 markers. The genotype data were imputed using the GenomeAsia reference panel and GPS CAD was determined. The GPS CAD was applied to all patients in the cohort. The following were determined (i) relationship between GPS CAD and CAD (ii) association between GPS CAD and incidence of preoperative renal dysfunction (iii) influence of GPS CAD on development of postoperative AKI and (iv) influence of a composite genetic predisposition to AKI in OP-CABG and GPS CAD on the surgical outcome. Results: The GPS CAD was generated for all samples in the four groups and was binned into 10 groups (deciles), in the ascending order of GPS CAD. The first decile (lowest GPS CAD bin) comprised ~60% of healthy controls, and 22% group A, 11% group B, and 7 % group C. . No difference was observed in GPS CAD between AKI and non-AKI samples belonging to group A. Conclusions: In summary, our results suggest no impact of GPS CAD on the presence of kidney dysfunction and incidence of AKI after off-pump CABG.