Oral route of administration is widely accepted and desired because of its versatility, convenience, and most importantly patient compliance. Multiparticulate systems like granules and pellets are more advantageous when compared to single-unit dosage forms, as they are capable to distribute the drug more evenly in the gastrointestinal tract. The current paper focuses on pellets, the merits and demerits associated, various pelletization techniques, and its characterization. It also focuses on how pellets can be employed for drug delivery in controlled and sustained release formulations. It gives a com-plete emphasis on the drug and excipients that can be used in pellet formation, the marketed formulations, and the research pertaining to pellets.

Four trade disputes concerning animal diseases have undergone the formal dispute resolution procedure of the World Trade Organization (WTO). These cases clarify a number of provisions of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). A national measure that contradicts a standard set by the World Organisation for Animal Health (OIE), for example by prohibiting a product that is permitted under the OIE standard, is not 'based on' that standard. Such a measure must be based on an appropriate risk assessment. For animal diseases, this means not only assessing the likelihood of entry, establishment or spread of the disease, and the associated biological and economic consequences, but also assessing each feasible mitigation measure. Any mitigation measure imposed must be rationally supported by the risk assessment. A highly trade-restrictive measure, such as a ban, is more easily justified if the identified risk is high. A measure imposed to protect health cannot impose stricter requirements on one product than on another with a similar level of risk. A WTO Member acts inconsistently with the SPS Agreement if an alternative measure, which is technically and economically feasible and restricts trade less, would achieve the desired level of protection. Countries must adapt their SPS requirements to reflect the disease risk of the area or zone from which a product comes and for which it is destined. Procedures to assess risk and determine the disease status of a region must be completed without unjustified delays, and only the information necessary for this can be requested of the exporter. KeywordsAgreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) -Animal health -Disease-free areas -Dispute settlement -International standard -Risk assessment -World Trade Organization (WTO).

Background and Introduction: Saxagliptin is a hypoglycemic drug that acts as a dipeptidyl peptidase-4 (DPP-4) inhibitor and is preferably used in the treatment of Type 2 Diabetes Mellitus (T2DM). It is safe and tolerable; however, the major disadvantage associated with it is its low bioavailability. Aim: The present research aimed to enhance the bioavailability of the drug by enteric coating with a polymer that controls the rate of drug delivery, and it was prepared as Solid Lipid Nanoparticles (SLNs). Methodology: In the current study, various SLN formulations were developed using a central composite design (CCD) module using Design Expert-11 software. A modified solvent injection technique was used to prepare Saxagliptin nanoparticles coated with Eudragit RS100. The CCD was used to determine the independent variables and their effect on dependent variables at varied levels. Evaluation studies such as particle size analysis, Zeta potential, polydispersity index (PDI), drug loading, entrapment efficiency, in-vitro drug release studies, and in vivo pharmacokinetic studies were performed for the optimized SLN formulation. The reversed-phase HPLC method was developed and validated for the estimation of the pharmacokinetic parameters of the pure drug and prepared SLNs. Results: The effect of independent variables (A1: amount of lipid, A2: amount of polymer, A3: surfactant concentration, and A4: homogenization speed) on dependent variables (R1: particle size, and R2: entrapment efficiency) was established in great detail. Observed responses of the prepared and optimized Saxagliptin SLN were close to the predicted values by the CCD. The prepared SLNs depicted particle sizes in the range of 212–442 nm. The particle size analysis results showed that an increase in the lipid concentration led to an increase in particle size. The developed bioanalytical method was noted to be very specific and robust. The method accuracy varied from 99.16% to 101.95% for intraday, and 96.08% to 103.12% for inter day operation at low (5 mcg/mL), moderate (10 mcg/mL), and higher (15 mcg/mL) drug concentrations. The observed Zeta potential values for the prepared SLNs were in the range of −41.09 ± 0.11 to 30.86 ± 0.63 mV suggesting quite good stability of the SLNs without any aggregation. Moreover, the polydispersity indices were in the range of 0.26 ± 0.051 to 0.45 ± 0.017, indicative of uniformity of sizes among the prepared SLNs. In vivo study outcomes proved that Saxagliptin oral bioavailability significantly enhanced in male Albino Wistar Rats via SLN formulation and Eudragit RS100 coating approach. Conclusions: The developed and optimized Saxagliptin SLNs revealed enhanced Saxagliptin bioavailability in comparison to the native drug. Thus, this formulation strategy can be of great importance and can be implied as a promising approach to enhance the Saxagliptin bioavailability for facilitated T2DM therapy.