scholarly journals Formulation and Pharmaceutical Assessment of Annona muricata Oral Capsules and Suspension as Antidiarrhea Dosage Forms

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Frederick William Akuffo Owusu ◽  
Mariam El Boakye-Gyasi ◽  
Philomena Entsie ◽  
Christina Osei-Asare ◽  
Ofosua Adi-Dako ◽  
...  

Annona muricata (Annonaceae) is a tropical plant widely known for its edible fruits. Recent scientific studies have confirmed the folkloric use of its seeds as an antidiarrheal agent. This study sought to formulate capsules and suspensions using the ethanolic extract from Annona muricata seeds. The dried ethanolic extract was formulated into granules and subsequently encapsulated. The suspension formulated was assessed for sedimentation rate, sedimentation volume, viscosity, dissolution, drug content, and flow rate, while pharmacopeia tests such as disintegration, dissolution, uniformity of weight, and drug content were carried out on the formulated capsules. The formulated suspension passed the drug content and in vitro release studies. Annona muricata suspension exhibited pseudoplastic flow with good sedimentation rate and sedimentation volume. The formulated capsules passed the in vitro dissolution studies, weight uniformity, disintegration, and drug content tests. The ethanolic extract of Annona muricata seeds was appropriately formulated into standardized solid and liquid oral dosage forms.

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Fredrick W. A. Owusu ◽  
Christiana O. Asare ◽  
Philomena Enstie ◽  
Ofosua Adi-Dako ◽  
Genevieve Naana Yeboah ◽  
...  

Management of diarrhea has evolved over the years from relatively inadequate interventions in the early years to more successful physiological approaches. The use of herbal medicinal products and supplements has grown significantly over the past three decades, with more than half of the global population depending on it for some aspect of their primary health care needs. This study is aimed at formulating solid and liquid oral dosage forms of the ethanolic extract of Cola nitida seeds for the treatment of diarrhea. The flow property of the dried ethanolic extract was determined and subsequently formulated into granules for encapsulation. The ethanolic extract was also used in formulating an oral suspension. Pharmacopeia tests such as uniformity of weight, disintegration, drug content, and dissolution were carried out on the formulated capsules. The formulated suspension was also assessed using the following parameters; viscosity, flow rate, drug content, dissolution, sedimentation rate, and sedimentation volume. The dried ethanolic extract and formulated granules exhibited good flow properties. The formulated capsules exhibited optimal in vitro release of extract (>90% after 45 minutes) and passed the uniformity of weight, disintegration, and drug content tests. The formulated suspension also passed the drug content test and had a good sedimentation rate, sedimentation volume, and flow rate. The formulated suspension also exhibited pseudoplastic flow, optimal viscosity, and a good in vitro release profile (>90% after 45 minutes). Capsules and suspension of the ethanolic extract of Cola nitida seeds have been successfully formulated and can be used as standard dosage forms for the management of diarrhea.


2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.


2020 ◽  
Vol 27 (2) ◽  
pp. 32-40
Author(s):  
João Luis S. de Oliveira ◽  
Gilmar A. C. Teles Júnior ◽  
Desirée A. Bonfim ◽  
Carlos Magno R. Carvalho Júnior ◽  
Jéssica A. Santos ◽  
...  

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Samuel Korsah ◽  
Stephen Yao Gbedema ◽  
Marcel Tunkungmen Bayor ◽  
Mariam El Boakye-Gyasi ◽  
Frederick William Akuffo Owusu ◽  
...  

Plant medicine is commonly employed to treat malaria and other infections in Ghana. However, many of these phytomedicines have not been scientifically investigated to justify their use. This study therefore sought to investigate the antimalarial property of Polyalthia longifolia leaves and to formulate suitable dosage forms for ease of administration. A four-day antiplasmodial suppressive and curative study was conducted on ethanol extract of P. longifolia leaves (PLE) using Plasmodium berghei infected albino mice. Tablet and suspension dosage forms of PLE were formulated and evaluated for quality and stability. Statistically significant ( P < 0.05 ) parasitaemia suppression (61.25%) and cure (58.78%) were achieved at a PLE dose of 100 mg/kg, and increases in hematological indices ( P < 0.001 ) were also observed in the PLE-treated mice as compared to the untreated group. The tablets passed the tests for uniformity of weight, friability (<1%), hardness, disintegration (<15 minutes), and in vitro dissolution (>70% release in 45 minutes). The sedimentation volume, rheology, viscosity, and pH of the formulated suspension were within the official specifications. The dosage forms showed consistency in PLE content (85–105%) and no changes in physicochemical properties over the six months period of stability study. The in vivo antimalarial activity of PLE has been established and oral dosage forms that conformed to Pharmacopoeial standards are formulated for use in the management of malaria.


Author(s):  
Umamaheswara G. ◽  
Anudeep D.

Fluvastatin sodium is a novel compound used as cholesterol lowering agent which acts through the inhibition of 3- hydroxyl-3- methyl glutaryl- coenzyme A (HMG-Co A) reductase. It has short biological half life (1-3h) in humans required a dosing frequency of 20 to 40mg twice a day. Due to its short variable biological half life it has been developed to a sustained gastroretentive system with a natural and synthetic polymer and to study how far the natural mucilage improves the sustained activity. Floating tablets were prepared by direct compression method using in combination of natural mucilage and synthetic polymer. Prior to the preparation of tablets the physical mixtures were subjected to FT IR studies and pre compression parameters. After preparation of tablets they were subjected to various tests like swollen index, drug content, In vitro dissolution and release kinetics with pcp disso software etc. The tablets prepared by direct compression shown good in thickness, hardness and uniformity in drug content, the prepared tablets floated more than 12h except FS1 and FS2 shows 9 and 11h. Swollen index studies shows with increase in concentration of polymer the swelling increases the diffusion path length by which the drug molecule may have to travel and cause lag time. In vitro results shows that on increasing the amount of hibiscus polymer the sustain activity is increased because of its integrity and forms a thick swollen mass and reduces the erosion property of the HypromelloseK100M, kinetic studies shows that FS 1, FS2, FS3 followed the Korsmeyer peppas model and the rest FS 4, FS 5, FS6 follows the zero order respectively. Based on n value indicating that the drug release followed super case II transport mechanism due to the erosion of the polymer.


Author(s):  
R. Nagaraju ◽  
Rajesh Kaza

Salbutamol and theophylline are available in conventional dosage forms, administered four times a day, leading to saw tooth kinetics and resulting in ineffective therapy. The combination of these two drugs in a single dosage form will enhance the patient compliance and prolong bronchodilation. Various polymers, such as hydroxy propyl methylcellulose K4M (HPMC- K4M), hydroxy propyl methylcellulose K100M (HPMC- K100M), xanthan gum, ethyl cellulose and hydroxy propyl methylcellulose phthalate (HPMC-P) were studied. HPMC-P and HPMC- K4M were found to be best in controlling the release. In-vitro dissolution studies were carried out for all the bi-layered tablets developed using USP dissolution apparatus type 2 (paddle). It was found that the tablet FB15-FW3 showed 50% release of salbutamol in first hour and the remaining was released for eight hours. However, theophylline was found to be released as per the USP specifications. The IR spectrum was taken for FB15-FW3 formulation and it revealed that there is no disturbance in the principal peaks of pure drugs salbutamol and theophylline. This further confirms the integrity of pure drugs and no incompatibility of them with excipients. Also, formulation of FB15-FW3 has shown required release pattern and complies with all the evaluated parameters and comparable to the marketed formulation.


Author(s):  
Sudarshan Singh ◽  
S S Shyale ◽  
P Karade

The aim of this study was to design orally disintegrating tablet (ODT) of Lamotrigine. It is an Antiepileptic drug which is widely used in epilepsy. It is also used in simple and complex partial seizures and secondary generalized tonic-clonic seizures. It is poorly water soluble drug (0.46 mg/ml). Thus, an attempt was made to enhance the water solubility by complexation with β-cyclodextrin (1:1 molar ratios). The orally disintegrating tablet of lamotrigine was prepared by direct compression method using different concentration of superdisintegrants such as Sodium starch glycollate, croscarmellose sodium by sublimating agent such as camphor. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies. The prepared tablets were characterized by Fourier transform infrared spectroscopy and differential scanning calorimetry. The disintegration time for the complexed tablets prepared by different concentration of superdisintegrants was found to be in range of 32.54 ± 0.50 to 55.12 ± 0.57 sec and wetting time of the formulations was found to be in range of 28.47 ± 0.67 to 52.19 ± 0.72 sec. All the formulation showed almost 100 percent of drug release within 15 min. Among all the formulation F6 and F7 prepared with 18% croscarmellose sodium and camphor shows faster drug release, respectively 10 min, F6 gives good result for disintegration time, drug release, wetting time and friability. Further formulations were subjected to stability testing for 30 days at temperature of 40 ± 5 ºC/75 ± 5 %RH. Tablets showed no appreciable changes with respect to physical appearance, drug content, disintegration time and dissolution profiles. Results were statistically analyzed by one-way ANOVA at a p < 0.05. It was found that, the data at any point of time are significant at p < 0.05.


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