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Spray Drying and Pharmaceutical Applications
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Metin Çelik, Pavan Muttil, Gülşilan Binzet, Susan C. Wendell
The knowledge acquired for these factors during the structured product and process development studies can assure the quality of the spray dried product as one would expect an inverse relationship between the level of process understanding and the risk of producing a poor-quality product. In this respect, there were studies conducted before the publication of the FDA’s PAT guidelines. An example of such a study involved the use of experimental factorial designs to investigate the effects of a number of formulation and process parameters on production yields and moisture contents of spray dried products. These factors concerned both the solution feed (drug concentration, colloidal silica concentration, and polymer/drug ratio) and the spray dryer (inlet temperature and feed rate). In this study, the optimal operating conditions were estimated by response surface methodology. Central rotational composite designs showed that quadratic models were found to be adequate. The results showed that the control of processing variables, especially inlet temperature and feed rate, allowed the production of microparticles of low moisture content with high yields. An experimental factorial design was claimed to be necessary before new production runs to determine the values of the parameters to be used for the optimization of the spray drying process [155].
Emblicanin-A and Emblicanin-B: Pharmacological and Nano-Pharmacotherapeutic Perspective for Healthcare Applications
Published in Debarshi Kar Mahapatra, Cristóbal Noé Aguilar, A. K. Haghi, Applied Pharmaceutical Practice and Nutraceuticals, 2021
Mohamad Taleuzzaman, Debarshi Kar Mahapatra, Dipak Kumar Gupta
The Chitosan-Gallic acid (GA-CH) based on nanoformulation was used for the preparation of different pharmaceutical dosages. First, the nanoparticle CH was prepared and optimized. The formulation validated by Response Surface Methodology (RSM) employing the analysis of ZP and percentage encapsulation efficiency. The nanoparticles were prepared by ionotropic gelation using tripolyphosphate (TPP), at different combinations of CH concentration, CH:TPP ratio, and GA. The analysis performed confirmed the FTIR data with both hydrogen bond and ionic interactions of CH–TPP which allowed the encapsulation and the improvement of the stability of the active agent.36
Effect of UAFF Process Parameters on Wettability and Bacterial Adhesion
Published in S Santhosh Kumar, Somashekhar S. Hiremath, Role of Surface Modification on Bacterial Adhesion of Bio-Implant Materials, 2020
S Santhosh Kumar, Somashekhar S. Hiremath
Further, the wettability of the finished surface is studied by measuring the contact angle (θ) for three different liquids – water, formamide and diiodomethane by sessile drop technique using the contact angle Goniometer instrument. The measured contact angles are used to ascertain the surface free energy components using a van-Oss-Chaudhury-Good equation. The significant difference is observed on surface roughness, contact angle and surface energy of the machined surfaces at different finishing cycles. Also, the various tendencies of the droplet contact angle and surface energy have been observed along the finishing direction parallel and perpendicular, and it ascertained the firm conclusion that surface roughness and surface morphology play a significant role in wetting characteristics. Further, the response surface methodology (RSM) model has been used to optimize the input parameters such as a number of cycles and pressure to obtain desired output responses, namely, Ra and material removed (MR). Interactive effects of a number of cycles and pressure on the Ra and MR are discussed in this section.
Utilization of propranolol hydrochloride mucoadhesive invasomes as a locally acting contraceptive: in-vitro, ex-vivo, and in-vivo evaluation
Published in Drug Delivery, 2022
Mahmoud H. Teaima, Moaz A. Eltabeeb, Mohamed A. El-Nabarawi, Menna M. Abdellatif
Several trials were performed to evaluate the impact of the independent variables. Response surface methodology is based on the experimental design that aims to determine the best variables for a specific target of the response, utilizing minimal experiments (Aboelazayem et al., 2018). The prepared INVs were optimized via applying D-optimal design using Design-expert® which produced 20 experimental trials. The model selected was quadratic for EE%, and Q6h (%) while it was linear and 2FI for PS and ZP, respectively. For adequate- precision a ratio greater than 4 is preferred which was observed for all dependent variables as illustrated in Table 2. The predicted R2 values were in correspondence with the adjusted R2 in all dependent variables (Table 2).
Quality by design (Qbd) assisted development of phytosomal gel of aloe vera extract for topical delivery
Published in Journal of Liposome Research, 2021
Pooja Jain, Mohamad Taleuzzaman, Chandra Kala, Dipak Kumar Gupta, Asad Ali, Mohammed Aslam
Phytosomes were successfully prepared and optimized through Design expert software. Central composite design with response surface methodology was applied. As shown in Table 1, concentration range of lecithin was selected as 0.15–0.25% w/v and speed of rotation as 80–160 rpm. A total of 13 formulation batches were prepared as shown in Table 2 and the effect of these two independent variables was studied on the dependent variables such as vesicular size and entrapment efficiency. All the experiments were performed in triplicate manner. After the analysis of responses, constraints for the independent and dependent variable were selected to create a design space. The constraints for the independent variable, that is, lecithin concentration and speed of rotation were selected in the range where acceptable results were obtained and constraints for the dependent variable were selected (Table 3). The design was validated by repeating the solution of highest desirability and comparing the predicted results for dependent factors with the obtained values. Standard error was also determined.
Solid lipid nanoparticles by Venturi tube: preparation, characterization and optimization by Box–Behnken design
Published in Drug Development and Industrial Pharmacy, 2021
Gilberto García-Salazar, María de la Luz Zambrano-Zaragoza, Eduardo Serrano-Mora, Sandra Olimpia Mendoza-Díaz, Gerardo Leyva-Gomez, David Quintanar-Guerrero
There are two ways to reach the goals of experimental research. The first consists of the variation of one factor at a time while maintaining all others constant. However, this step-by-step method is tedious and does not show the interaction between two or more factors [12]. The second approach uses an experimental design that is efficient for estimating the effects of several variables simultaneously using a factorial approach. A statistical factorial design makes it possible to analyze several variables simultaneously and provides information not generated in classical experimental methods, namely, interactions among variables [13]. The Response Surface Methodology is one approach that can evaluate the relations between the response and independent variables simultaneously [14] while helping to determine the optimum operating conditions to decrease the number of experiments required. The Box-Behnken design in our study allowed us to use fewer experiments than the central composite or three-level full factorial design. The explanation is that this design does not require experiments at the experimental region's vertices to avoid performing procedures under extreme conditions that can make such experiments difficult to conduct adequately [15].