Research Article
Formulation and Ex Vivo Evaluation of Membrane Permeation Properties of a Mixed Acetaminophen Gel for Rectal Administration
Issue:
Volume 8, Issue 2, December 2024
Pages:
18-23
Received:
3 July 2024
Accepted:
30 July 2024
Published:
20 August 2024
Abstract: The purpose of this work was to evaluate the permeation of a mixed native starch-based gel of Ipomoea batatas (Convolvulaceae), using acetaminophen as a tracer through a rat rectal membrane (ex vivo method). The formulated gel was composed of a 10 g solution of poloxamer 407 at 20% and 2.5 g of glycerolized potato starch. The gel obtained was a smooth, homogeneous mixed gel with no foam, air bubbles or lumps, there was no characteristic odor, and the gel was whitish in color. This gel was characterized at the physicochemical and rheological level by means of the viscosimeter KINEXUS, pH- meter EUTECH and the study of the permeation was carried out by means of the Ussing chamber of horizontal type (the dual chamber). The formulated mixed gel is thermogelling, rheofluidifying and viscoelastic with a gelling temperature of 23.83; the permeation study gave a relatively low permeation percentage of 0.16% but which can be improved. The different viscoelastic, rheofluidizing and thermogelling characteristics contained in this mixed gel as well as the pH did not influence the permeation of the active ingredient (AP) through the rat rectal mucosa.
Abstract: The purpose of this work was to evaluate the permeation of a mixed native starch-based gel of Ipomoea batatas (Convolvulaceae), using acetaminophen as a tracer through a rat rectal membrane (ex vivo method). The formulated gel was composed of a 10 g solution of poloxamer 407 at 20% and 2.5 g of glycerolized potato starch. The gel obtained was a smo...
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Research Article
Formulation and in vitro Evaluation of Liquisolid Compact of Celecoxib
Ezegbe Chekwube Andrew*
,
Anikwe Celestine Chidera,
Okorie James Ekemezie,
Okafor Nnedimma Pauline,
Amarachi Grace Ezegbe,
Nwankwo Emmanuel Chinedu,
Okorafor Ezinne Chinemerem
Issue:
Volume 8, Issue 2, December 2024
Pages:
24-46
Received:
9 June 2024
Accepted:
27 June 2024
Published:
20 September 2024
Abstract: Introduction: The liquisolid technique presents a promising avenue for enhancing the dissolution rate and bioavailability of poorly water-soluble drugs like celecoxib. This study investigated the formulation and evaluation of celecoxib tablets using this technique. Aim: To formulate and evaluate celecoxib tablets using the liquisolid technique, with the objective of enhancing its dissolution rate and bioavailability. Methods: Celecoxib tablets were prepared using the liquid-solid technique by incorporating a non-volatile liquid medication carrier and a suitable solid carrier. Various formulations were developed by altering the ratios of drug, carrier, and coating materials. The prepared tablets were characterized for their physical properties, drug content uniformity, in vitro dissolution behavior, and compatibility using Fourier-transform infrared (FTIR) spectroscopy. Results: The solubility profile showed that the maximum rate of solubility was recorded in PEG-400 (11.03 ± 0.01) when compared to other non-volatile solvents. The angle of slide, indicated that the excipients used were within the acceptable limit of 33°. The FTIR spectroscopy showed compatibility of the drug and excipients. The results of the SEM showed that spherically-shaped vesicles were formed. Evaluation of the pre-compression parameters indicated that the drug content was highest in batch F-11 hence its optimization (96.1 ± 0.90). The post compression evaluation indicated that the official tests were within the acceptable range for disintegration time (2.25 ± 0.35). The results of the in vitro release studies of the optimized formulation, conventional tablet and reference commercial tablet showed that the amount of drug released increased steadily with time over the 1-hour period. Conclusion: Our findings underscore its viability as a strategy to enhance the therapeutic efficacy of poorly water-soluble drugs, offering promising prospects for pharmaceutical formulation.
Abstract: Introduction: The liquisolid technique presents a promising avenue for enhancing the dissolution rate and bioavailability of poorly water-soluble drugs like celecoxib. This study investigated the formulation and evaluation of celecoxib tablets using this technique. Aim: To formulate and evaluate celecoxib tablets using the liquisolid technique, wit...
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Research Article
Risk Assessment for Environmental Monitoring of the Injectable Cephalosporins and Carbapenems Production Plant
Issue:
Volume 8, Issue 2, December 2024
Pages:
47-55
Received:
19 July 2024
Accepted:
11 September 2024
Published:
31 October 2024
DOI:
10.11648/j.pst.20240802.13
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Abstract: Introduction: Operations with medicines require compliance with the requirements established in Good Practices with the objective of guaranteeing their quality, safety and effectiveness. The Quality Management System incorporates quality risk management as an integral part. In the injectable plant, the aseptic processing of Cephalosporins and Carbapenems is carried out in the form of sterile powders for injection. Production is subject to special requirements to minimize the risks of microbial, particulate and pyrogen contamination. The environmental microbiological monitoring program is one of the critical elements in the production process; it must be applied routinely and periodically. The objective of this work is to carry out risk assessment in the environmental monitoring process of controlled areas of the plant by identifying the risk points and the causes that originate them and establishing preventive and/or corrective measures to minimize their frequency and impact on processes. Materials and Methods: Failure Modal Analysis and Process Effects are used for risk assessment; it is a prevention method aimed at achieving Quality assurance. Supporting techniques such as Brainstorming and Cause-Effect Diagram were also used. Results: Through the application of this technique, reference criteria are obtained for monitoring viable and non-viable particles in the environment, monitoring frequencies, sampling frequency and number of sampling points according to m2 of the area to be monitored and determination of points by priority level. Discussion: A flow chart of the process is built to analyze the inputs of raw materials and the most critical points where contamination can be generated for different causes. The identification of risks was carried out by applying the brainstorming technique and as a result, 4 critical areas with a high probability of contamination occurrence were determined. By building the Ishikawa diagram of the process to be improved, the environmental monitoring program becomes a powerful tool to avoid the undesired effect, which is product rejection. The risk priority number was calculated for each failure mode and corrective measures were established to mitigate the effect level. Conclusions: As a result of the risk assessment in the environmental monitoring process of controlled areas, risks were identified and evaluated in order of criticality. Preventive and/or corrective measures were established for each stage in order to reduce the possibility of risks of product contamination.
Abstract: Introduction: Operations with medicines require compliance with the requirements established in Good Practices with the objective of guaranteeing their quality, safety and effectiveness. The Quality Management System incorporates quality risk management as an integral part. In the injectable plant, the aseptic processing of Cephalosporins and Carba...
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