Effect of Accelerated-Aging Conditions on the Dissolution Stability of Ciprofloxacin Tablets

Vidal, Noelia L. González; Brevedan, Marta I. V.; Varillas, María A.; Simionato, Laura D.; Pizzorno, M. T.

doi:10.14227/dt170110p23

Cited by 4 publications

(4 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Pellets with only enteric coated alone (A) ruptured surface was observed Figure 3 moreover; more than 50% of drug were release at the end of 2h Figure 5, Table (8). Whereas Pellets with over coated (A*) was showed smooth surface Figure 4 and no significant change in drug release pattern Figure 5, Table 8.…”

Section: Stability Studiesmentioning

confidence: 92%

“…Thus, if they used as enteric polymer the film can suffer from severe damages which leads to loss of enteric properties of the dosage form. To overcome this restriction previous workers in the field of enteric coating have found it necessary to over coat with a cellulose derivatives to prevent brittleness of the polymer and improve the stability of the product 8 . 2.25gms of HPMC and 3.87gms of PEG 6000 were dissolved in 207 ml of each of isopropanol and acetone under magnetic stirrer it would be considered as an over coating solution.…”

Section: Over Coatingmentioning

confidence: 99%

See 1 more Smart Citation

Impact of Over Coat Application on Enteric Coated Drug Pellets: Designed to Protect From Stomach Environment

Swamykannu¹,

Vangadari²,

Yalamanchili³

2016

Int. Res. J. Pharm.

View full text Add to dashboard Cite

Omeprazole is an antisecretory compounds called proton pump inhibitors. Omeprazole is an acid labile drug so enteric coated pellets were formulated using pan coating process. Two different groups of pellets were prepared, one group of pellets consists drug layer coat, enteric layer coat and another group of pellets consists of drug layer coat, enteric layer coat and over coat. The pellets were optimized with the acid resistance and drug release in simulated intestinal fluid as the process parameters. Other properties, such as moisture content, particle size, resistance to abrasion and drug content also studied. The over coat application played a vital role in acid resistance it protects the drug release in stomach environment. Three month accelerated stability studies, showed over coated pellets to be stable.

show abstract

Section: Stability Studiesmentioning

confidence: 92%

Section: Over Coatingmentioning

confidence: 99%

Impact of Over Coat Application on Enteric Coated Drug Pellets: Designed to Protect From Stomach Environment

Swamykannu¹,

Vangadari²,

Yalamanchili³

2016

Int. Res. J. Pharm.

View full text Add to dashboard Cite

show abstract

“…The tablets exposed to various aging conditions such as pH, temperature, photolytic conditions and high or low humidity etc, may affect the release characteristics of drug. [5,6,7,8].…”

Section: Introductionmentioning

confidence: 99%

Investigation on Effect of Stress on Dissolution Stability of Drug Product by Applying Thermal and NonThermal Methods of Analysis

Gupta

Chaudhari

Pounikar

et al. 2019

AJACR

View full text Add to dashboard Cite

Aim: The aim of the research work has to development and validation of dissolution test method for Tapentadol using HPLC method, investigate the effects of stress on dissolution stability by thermal and non-thermal methods. The present research work mainly focused on the evaluation and compares the influence of accelerated-aging conditions on the drug content and in vitro dissolution stability. Place and duration of Study: Department of Pharmaceutical Chemistry, Smt. Kishoritai Bhoyar College of Pharmacy, New Kamptee, Nagpur (MS). Methodology and Results: Saturated solubility study of tapentadol were carried out using different dissolution media and different conditions such as type of dissolution medium, volume of dissolution medium and rotation speed of paddle were evaluated. Basis of it, dissolution testing were carried out on a suitably calibrated USP Apparatus II (TDT-06L) at 50 ± 1 rpm, under sink conditions in 900 mL of deaerated distilled water at 37±0.5ºC for each test and selected most optimized dissolution parameter which given maximum % release of drug. The drug release was evaluated by high-performance liquid chromatographic method. Also proposed method were validated as per ICH guidelines with respect to system suitability, linearity, precision, accuracy, range, robustness, ruggedness and solution stability parameters were evaluated and the obtained results were within the acceptable range. The stress on dissolution stability of standard powdered drug, tablet formulation and packed strip formulation were investigated by using thermal and non thermal methods. The results obtained in all stress conditions such as thermal, humidity, UV light and visible light were evaluated for drug content and drug release. The results were statistically evaluated by applying two-way ANOVA followed by post-hoc Bonferroni test and their results represented as a graphical plot. Conclusion: In our investigation of stress dissolution of drug it was found that Tapentadol HCl std. drug was susceptible to degradation. The tablet and packaged formulation were susceptible to photolytic degradation indicated by difference in drug content while the release was more affected under UV exposed to tablet and strip packaged formulation as compared to other stress conditions.

show abstract

“…Although there is a regulatory prerogative requiring the completion of the dissolution test for the stability study, there is no requirement for an analysis of the dissolution profile. Few authors have demonstrated the manner in which it makes a difference (Ochi et al, 2016;Payghan et al, 2012;Vidal et al, 2010).…”

Section: Introductionmentioning

confidence: 99%

Prednisone raw material characterization and formulation development

Toehwé¹,

Prado

Rocha

2018

Braz. J. Pharm. Sci.

View full text Add to dashboard Cite

Solid dosage forms for oral use, particularly tablets, are the most highly used dosage forms in therapy because they are easily administered, have high productivity and relatively low cost and provide a more stable drug to form a semi-solid net. Numerous parameters influence the quality of the final dosage form. In this study, the dissolution profile of 20-mg prednisone tablets bioequivalent to the reference product and three test formulations were evaluated using stability testing. During the study, prednisone tablets and the active pharmaceutical ingredient (API) prednisone from two different manufacturers were characterized with respect to their physical and physicochemical properties. The results showed that the dissolution profiles of the test batches and the reference product did not retain pharmaceutical equivalence throughout all the stability study. Notably, both samples of API prednisone were of the same crystal form, and any phase transition that occurred during the study could not be attributed to dissolution variation during stability.

show abstract

Effect of Accelerated-Aging Conditions on the Dissolution Stability of Ciprofloxacin Tablets

Cited by 4 publications

References 8 publications

Impact of Over Coat Application on Enteric Coated Drug Pellets: Designed to Protect From Stomach Environment

Impact of Over Coat Application on Enteric Coated Drug Pellets: Designed to Protect From Stomach Environment

Investigation on Effect of Stress on Dissolution Stability of Drug Product by Applying Thermal and NonThermal Methods of Analysis

Prednisone raw material characterization and formulation development

Contact Info

Product

Resources

About