In Ghana, the encapsulated blend of the powdered stem and root bark of Cassia sieberiana is prescribed and dispensed to patients at the Centre for Plant Medicine Research (CPMR), for the management of dysmenorrhea and gastric ulcer pain. This current formulation has significant challenges in manufacturing and optimization of therapeutic outcomes due to lack of standardization of actual quantities of the extracts obtained from ingestion of the product. The study sought to formulate and evaluate capsules of Cassia sieberiana using the stem and root bark. Extraction was undertaken with different solvents: absolute ethanol (F1) and 70% ethanol (F2). These 2 formulations were compared to the existing product (MP1) by CPMR. Granules for encapsulation were prepared by wet granulation and their flow properties compared with MP1. Drug-excipient compatibility was studied using FT-IR, TLC and UV. Quality control tests on MP1, F1 and F2 capsules were conducted using pharmacopoieal methods. From the results obtained, organoleptic and physicochemical properties of the extracts demonstrated its suitability for use in oral capsule formulation. MP1, F1 and F2 recorded a λmax of 278 nm, 278 nm and 276 nm, respectively. The extract per dose of capsules was found to be 27.84 ± 0.11 mg and 36.65 ± 0.03 mg for F1 and F2, respectively. Granules of F1 and F2 had good flow properties whereas MP1 demonstrated a fair flow property. FT-IR spectra showed possible interaction between extracts and excipients. However, TLC results indicated similar compounds present in the extracts and granules. The UV marker analysis also indicated no interaction since the percentage drug contents in F1 and F2 capsules were found to be 98.0% ± 1.40 and 98.90% ± 2.80 respectively. All 3 formulations passed the disintegration and uniformity of weight tests except MP1 which failed the latter. F1 capsules recorded the highest dissolution efficiency (99%) while MP1 recorded the lowest (22%). There was significant difference (p

Formulation and evaluation of capsules containing extracts of Cassia sieberiana for improved therapeutic outcome

The physicochemical properties of pharmacological molecules have a tremendous effect on safety and efficacy. Poor physicochemical properties can often make it hard to set up a reliable structure-activity relationship (SAR) with no prominent efficacy in preclinical and clinical models. This can lead to more variability in capability and higher drug development costs in the entire development process, and in the worst case, even to stop the clinical trials in the later period. Understanding the basic physicochemical properties makes it possible to separate and untangle investigational observations hence poor molecular properties can be changed or fixed during the design phase. This makes it more likely that the molecule will make it through the long and difficult development process. The decline in innovator pharmacotherapeutics number registrations decline each year and the industry is under even more pressure than in the past to speed up the drug development process. This reduces the length of time required for development and introduces innovative pharmaceutical products. To do this, it is imperative to proceed with an organised approach and act appropriately the first time. The current chapter aims to focus on the important physicochemical properties of the selected molecule, along with how those properties are evaluated and implicated in both discovery enablement and final dosage form development. 

/pdf/preformulation-studies-a-versatile-tool-in-formulation-1nb75cso.pdf

Preformulation Studies: A Versatile Tool in Formulation Design

Silybum marianum has been used for centuries by herbalists and physicians to treat different forms of liver diseases. It contains flavonoid, which has antioxidant, anti-inflammatory, antifibrotic and anticancer properties. The objective of this research was to develop a silymarin-based mucoadhesive gel for prolonged release in oral mucosa and to evaluate the same by using in vitro drug release kinetic models and ex vivo methods for drug permeation using chicken buccal mucosa. The mucoadhesive gel was formulated in different trials by varying the concentration of silymarin and polymer. Out of 10 formulation trials, the F10 optimized trial was characterized for in vitro physicochemical parameters such as pH, homogeneity, viscosity, stability, drug content, in vitro drug release, in vitro antioxidant assay and ex vivo permeation study. Trial 10 was chosen as the best trial formulation among the other trials and was marked as an optimal trial. The physicochemical properties observed were pH to be 6.4 ± 0.01, the gel free of lumps, spreadability of 23.75 ± 0.03 and drug content of 32.77 ± 0.20 mg/g. It had no physiological changes such as color shift or fluid exudate segregation after 6 months of storage at room temperature. In vitro drug release established the presence of a non-fickian mechanism and demonstrated dose-dependent antioxidant activity. Ex vivo findings indicated 21.97 ± 0.18% release, proving that the gel can permeate through the oral mucosal membrane. Our future research will concentrate on expanding the therapeutic scope by developing the formulation trial F10 to a nanoformulation and conducting clinical trials for its potential use in various oral diseases.

/pdf/preparation-and-characterization-of-silymarin-gel-a-novel-23iuu1b5.pdf

Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies

Drug Formulation Design [Working Title]

Compatibility Study Between Fenbendazole and Poly(Ethylene Oxide) with Application in Solid Dispersion Formulations Using Hot-Melt Extrusion

When a promising new chemical entity is synthesized, it needs transformation to appropriate formulation in order to show a better and desirable action at appropriate site. Preformulation study is a phase which is initiated once the new molecule is seeded. In a broader way, it deals with studies of physical, chemical, analytical, and pharmaceutical properties related to molecule and provides idea about suitable modification in molecule to show a better performance. Study of these parameters and suitable molecular modification can be linked to generation of effective, safer, stable, and reliable pharmaceutical formulation. Therefore, preformulation study is an approach for generation of pharmaceutical formulation which utilizes knowledge and area application of toxicology, biochemistry, medicinal chemistry, and analytical chemistry. The highlighted chapter is framed with a vision to provide an in-depth knowledge about pharmaceutical formulation development.

/pdf/preformulation-studies-an-integral-part-of-formulation-4ovg55bj7z.pdf

Preformulation Studies: An Integral Part of Formulation Design

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Preformulation Studies: An Integral Part of Formulation Design