scholarly journals A stability study on shelf life of mulberry juice in Malaysian SMEs’ (small medium enterprise)

2018 ◽  
Author(s):  
Zainon Mat Sharif ◽  
Mohd Syafiq Othman ◽  
Nurul Jannah Jalil
Keyword(s):  
Shelf Life ◽  
Stability Study ◽  
Medium Enterprise ◽  
Mulberry Juice

scholarly journals EVALUATION OF STABILITY OF ROPINIROLE HYDROCHLORIDE AND PRAMIPEXOLE DIHYDROCHLORIDE MICROSPHERES AT ACCELERATED CONDITION

2018 ◽  
Vol 10 (4) ◽  
pp. 82
Author(s):  
Koyel Kar ◽  
R. N. Pal ◽  
Gouranga Nandi
Keyword(s):  
Particle Size ◽  
Drug Release ◽  
Surface Morphology ◽  
Shelf Life ◽  
Stability Study ◽  
In Vitro Drug Release ◽  
Drug Content ◽  
Ropinirole Hydrochloride ◽  
Pramipexole Dihydrochloride

Objective: The objective of the present work was to conduct accelerated stability study as per international council for harmonisation (ICH) guidelines and to establish shelf life of controlled release dosage form of ropinirole hydrochloride and pramipexole dihydrochloride microspheres for a period of 6 mo.Methods: Most optimized batch of ropinirole hydrochloride and pramipexole dihydrochloride (F12 and M12 respectively) were selected and subjected to exhaustive stability testing by keeping the sample in stability oven for a period of 3 and 6 mo. Various parameters like surface morphology, particle size, drug content, in vitro drug release and shelf life were evaluated at 3 and 6 mo period. The surface morphology of the formulated microspheres was determined by scanning electron microscopy (SEM). The particle size of the microspheres was estimated by optical microscopy method. The drug content was assayed by the help of ultra-violet spectrophotometer (UV). The in vitro drug release was performed by using Paddle II type dissolution apparatus and the filtrate was analyzed by UV spectrophotometer. The shelf life of the optimized microspheres was calculated by using the rate constant value of the zero-order reaction.Results: A minor change was recorded in average particle size of F12 and M12 microspheres after storage for 6 mo. For F12 and M12, initially the particle size was 130.00 µm and 128.92 µm respectively and after 6 mo it was found to be 130.92 µm and 128.99 µm respectively. There was no change in surface morphology of F12 and M12 microspheres after 6 mo of storage. The shape of microspheres remained spherical and smooth after 6 mo. An insignificant difference of drug content was recorded after 6 mo compared to the freshly prepared formulation. For F12 and M12, 94.50% and 93.77% of the drug was present initially and after 6 mo 94.45% and 93.72% of the drug was recorded. In vitro drug release was recorded after 6 mo for F12 and M12. Initially, 97.99% and 97.69% of the drug was released till 14th hour respectively for F12 and M12. After 6 mo, 98.23% and 97.99% of the drug was released respectively. The percentage residual drug content revealed that the degradation of microspheres was low. Considering the initial percentage residual drug content as 100%, 99.94% of the drug was recorded for both F12 and M12. The shelf life for F12 and M12 was found to be 10 y 52 d and 10 y 70 d respectively which were determined by the zero-order kinetic equation.Conclusion: A more or less similar surface morphology, particle size, drug content and percent of drug release before and after stability study confirmed the stability of F12 and M12 microspheres after storage for 6 mo and prove the efficacy of the microspheres in the site-specific delivery of drugs in Parkinson’s disease.

scholarly journals Limitations and Challenges in the Stability of Cysteamine Eye Drop Compounded Formulations

2021 ◽  
Vol 15 (1) ◽  
pp. 2
Author(s):  
Cristina Martín-Sabroso ◽  
Mario Alonso-González ◽  
Ana Fernández-Carballido ◽  
Juan Aparicio-Blanco ◽  
Damián Córdoba-Díaz ◽  
...  
Keyword(s):  
Shelf Life ◽  
Stability Study ◽  
Eye Drops ◽  
Microbiological Analysis ◽  
Nitrogen Gas ◽  
Long Term Stability ◽  
Main Degradation Product ◽  
The Stability ◽  
Unstable Molecule

Accumulation of cystine crystals in the cornea of patients suffering from cystinosis is considered pathognomonic and can lead to severe ocular complications. Cysteamine eye drop compounded formulations, commonly prepared by hospital pharmacy services, are meant to diminish the build-up of corneal cystine crystals. The objective of this work was to analyze whether the shelf life proposed for six formulations prepared following different protocols used in hospital pharmacies is adequate to guarantee the quality and efficacy of cysteamine eye drops. The long-term and in-use stabilities of these preparations were studied using different parameters: content of cysteamine and its main degradation product cystamine; appearance, color and odor; pH and viscosity; and microbiological analysis. The results obtained show that degradation of cysteamine was between 20% and 50% after one month of storage in the long-term stability study and between 35% and 60% in the in-use study. These data confirm that cysteamine is a very unstable molecule in aqueous solution, the presence of oxygen being the main degradation factor. Saturation with nitrogen gas of the solutions offers a means of reducing cysteamine degradation. Overall, all the formulae studied presented high instability at the end of their shelf life, suggesting that their clinical efficacy might be dramatically compromised.

scholarly journals PARÂMETROS FÍSICOS NO ESTUDO DA ESTABILIDADE DAS EMULSÕES PHYSICALS PARAMETERS IN THE EMULSION STABILITY STUDY

2001 ◽  
Vol 2 (2) ◽  
Author(s):  
Sandra Maria W. Zanin ◽  
Marilis Dallarmi Miguel ◽  
Márcio Chimelli ◽  
Ana Cláudia Dalmaz
Keyword(s):  
Low Temperature ◽  
Shelf Life ◽  
Emulsion Stability ◽  
Subjective Evaluation ◽  
Stability Study ◽  
Physical Parameters ◽  
Geographic Locations ◽  
Pharmaceutical Manufacturers ◽  
Regulatory Acceptance ◽  
Artificial Stress

A estabilidade de uma emulsão definida pelo consumidor e muitas vezes pelo próprio formulador está baseada inteiramente em parâmetros subjetivos. Por isso, é importante lembrar que o padrão de estabilidade depende em larga escala do observador, e é esta a razão porque as observações subjetivas ou opiniões por si só não são suficientes para definir parâmetros como estabilidade aceitável. O tempo de prateleira de um produto e as condições de estresse artificiais são termos úteis para descrever a avaliação subjetiva da estabilidade de uma emulsão, contudo, e por esta mesma razão, os formuladores devem ser cautelosos para estabelecer a segurança e as condições de regulamentação dos componentes de uma emulsão para uma aplicação particular. O aspecto ou as características organolépticas de uma emulsão como a homogeneidade, brilho, macio, fino e opacidade, bem como o comportamento reológico e a espalhabilidade, estão entre os parâmetros físicos que devem ser avaliados, porque os produtos emulsionados podem ser transportados e utilizados em diversos locais do planeta com diferentes climas e condições de temperatura extremamente altas e baixas. Assim, os farmacêuticos devem possuir conhecimento pré-determinado da estabilidade de suas emulsões antes que elas possam ser comercializadas. PHYSICALS PARAMETERS IN THE EMULSION STABILITY STUDY Abstract Emulsion stability as defined by the consumer or even by the formulator is based entirely in subjective judgments. It is important, therefore, to remember that the standard of stability dependes to a large extent on the observer, since subjective observations or opinions by themselves do not suffice to define such a parameter as acceptable stability. Shelf life and artificial stress conditions are useful terms to describe the subjective evaluation of an emulsion stability, therefore, formulators are cautioned to establish the safety and regulatory acceptance of emulsion ingredients for a particular application. The emulsion aspect such us homogeneity, gloss, smooth, thin and dull, and rheologic behavior and spreadability were among the physical parameters that must be observed because emulsion products may be transported to and used in various geographic locations having varying climates and conditions of extremely high and low temperature. Thus, pharmaceutical manufacturers must have predetermined knowledge of their emulsion stabililty before they may be shipped.

scholarly journals HPLC-Based Analysis of Impurities in Sapropterin Branded and Generic Tablets

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 323
Author(s):  
Emanuela Scudellaro ◽  
Luciana Tartaglione ◽  
Fabio Varriale ◽  
Carmela Dell’Aversano ◽  
Orazio Taglialatela-Scafati
Keyword(s):  
Mass Spectrometry ◽  
Relative Humidity ◽  
Shelf Life ◽  
Orphan Drug ◽  
Chromatographic Method ◽  
Stability Study ◽  
Accelerated Stability ◽  
Definition Of

This work was aimed at the definition of a chromatographic method able to separate and quantify impurities present in sapropterin-containing drugs during an accelerated stability study. The chromatographic method was applied to the orphan drug Kuvan® and to its corresponding generic sapropterin Dipharma (Diterin®), both of which are approved for the treatment of hyperphenylalaninemia-induced symptoms. The two products tested had a similar manufacture date and both had an approved stability shelf-life of three years. Samples were analyzed by HPLC at T = 0 and after six months of storage at 40 °C and 75% relative humidity. Identification of the impurities was supported by a detailed mass spectrometry and MS/MS profile. The analysis demonstrated an overall higher stability for the Diterin® formulation, which was related to a lower increase of some impurities compared to Kuvan®.

scholarly journals A Study on Shelf Life Prolonging Process of Chili Soy Sauce in Malaysian SMEs’ (Small Medium Enterprise)

2017 ◽  
Vol 203 ◽  
pp. 012026
Author(s):  
Zainon Binti Mat Sharif ◽  
Norhasnina Binti Mohd Taib ◽  
Mohd Sallehuddin Bin Yusof ◽  
Mohammad Zulafif Bin Rahim ◽  
Abdul Latif Bin Mohd Tobi ◽  
...  
Keyword(s):  
Shelf Life ◽  
Soy Sauce ◽  
Medium Enterprise

scholarly journals Stability study of metronidazole cream, extemporaneously made in pharmacy

2021 ◽  
Vol 31 (Supplement_2) ◽  
Author(s):  
Andrius Dambrauskas
Keyword(s):  
Relative Humidity ◽  
Shelf Life ◽  
High Performance ◽  
Stability Study ◽  
Stress Factors ◽  
Alkaline Media ◽  
Acid Media ◽  
Microbiological Examination ◽  
The Face ◽  
The Stability

Abstract Background Rosacea is a chronic recurrent disease, characterized by facial redness, dilated blood vessels, inflammatory rash elements on the face. The pharmacy produces 2% metronidazole cream extemporaneously for the treatment of the disease, as there is no such cream concentration on the market. The treatment of the disease is usually long, so the shelf life of the cream is very important for the patient, especially for those who do not have the opportunity to reach the manufacturing pharmacy. The aim of this investigation was to determine the stability and shelf life of metronidazole cream. Methods Long-term stability study of metronidazole cream was applied at 25 ± 2° C, 60 ± 5% relative humidity; accelerated stability test at 40 ± 2 °C, 75 ± 5% relative humidity. The influence of stress conditions were evaluated on the stability of metronidazole cream. It was determined metronidazole cream texture and microbiological examination was applied. Results It was found that color (white), odor (odorless), integrity (homogeneous), pH (6.8) did not change during storage of metronidazole (6 months). Mechanical properties of the metronidazole cream: firmness, shear, consistency and cohesion throughout the study remained stable. High performance liquid chromatography in the full stability study showed that metronidazole concentrations did not fluctuate within ± 5%. Stress factors such as acid media, alkaline media, hydrogen peroxide, daylight and heat did not affect the stability of the cream. A microbiological examination of the metronidazole cream suited European Pharmacopoeia requirements. Conclusions The extemporaneously made metronidazole cream were stable for 6 months.

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