scholarly journals A Novel Stability Study of Simvastatin Generic Tablet in Public Pharmacy Facilities of Purwakarta District, Indonesia

2021 ◽  
pp. 548-562
Author(s):  
Muchtaridi Muchtaridi ◽  
Rini Yulianita ◽  
Iyan Sopyan ◽  
Amirah Mohd Gazzali

Drug stability is one of the most important criteria for producing safe, excellent and effective products. Some environmental factors that influence drug stability are light, temperature, and humidity. Simvastatin is a cholesterol-lowering drug that is known to be sensitive to high temperature and humidity. The purpose of this study is to analyze the effect of 6 months of real-time storage conditions on the stability of generic simvastatin tablets in public pharmacy facilities. This study used simulation method with 4 brands of simvastatin generic tablets with two different strengths (10 mg and 20 mg). In the process, the sample was conditioned in 6 different regions for 6 months. The results of temperature and humidity monitoring showed 2 locations at ≤ 25 ° C, 4 locations had a temperature of ≥ 25 °C and all locations had humidity > 65 %. The drug was evaluated for physical and chemical quality parameters at months 0, 3, and 6. After being stored for 6 months, the tablets showed a decrease in disintegration time and an increase in the friability, showing lack of durability. Similarly, there was a decrease in the content concentration in the tablets but fortunately the level was still within the accepted specification range (90 – 110 %). However, there was one tablet that did not meet the dissolution test requirements after the storage duration (Q ≤ 75 % at 30 minutes). The results of the stress test showed that simvastatin degraded in all conditions. This stress test confirmed the extreme instability of simvastatin.  Poor storage conditions can reduce the quality of generic simvastatin tablets, thus a well-controlled environment is vital in pharmacy facilities.

2020 ◽  
Vol 44 (6) ◽  
pp. 570-579 ◽  
Author(s):  
Emilia Marchei ◽  
Sara Malaca ◽  
Silvia Graziano ◽  
Massimo Gottardi ◽  
Simona Pichini ◽  
...  

Abstract Sampling and drug stability in oral fluid (OF) are crucial factors when interpreting forensic toxicological analysis, mainly because samples may not be analyzed immediately after collection, potentially altering drug concentrations. Therefore, the stability of some common drugs of abuse (morphine, codeine, 6-monoacetylmorphine, cocaine, benzoylecgonine, Δ9-tetrahydrocannabinol, cannabidiol, amphetamine, 3,4-methylenedioxymethamphetamine, ketamine) and the more commonly consumed new psychoactive substances in our environment (mephedrone, and N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide 5F-AKB48 also known as 5F-APINACA) was investigated in an OF pool for the presence and absence of M3 Reagent Buffer® up to 1 year of storage. Fortified OF samples were stored at three different temperatures (room temperature, 4 and −20°C) to determine the best storage conditions over time. Control fortified OF samples were stored at −80°C for reference purposes. Compounds with concentration changes within ±15% of initial value were considered stable. The drugs were significantly more stable in M3 Reagent Buffer® than in neat OF samples in all storage conditions. All analytes were stable for 1 year at 4°C and −20°C in M3 Reagent Buffer®. Drugs stability in OF varied depending on the analyte, the presence of a stabilizer, the storage duration and temperature. When immediate sample analysis is not possible, we suggest to store OF samples at 4 or −20°C and test them within 2 weeks. Alternatively, OF samples may be stored at 4 or −20°C with M3 Reagent Buffer® to be tested within 1 year.


Author(s):  
Avilash Carpenter ◽  
M.K. Gupta ◽  
Neetesh Kumar Jain ◽  
Urvashi Sharma ◽  
Rahul Sisodiya

Aim: The main of the study is to formulate and develop orally disintegrating fast dissolving tablet of Metoclopramide hydrochloride. Material & Methods: Before formulation and development of selected drug, the standard curve in buffer was prepared and absorbance at selected maxima was taken. Then two different disintegrating agents were selected and drug was mixed with disintegrating agents in different ratio. Various Preformulation parameters and evaluation of tablet i.e. disintegration time, dissolution time, friability, hardness, thickness were measured by standard procedure. Result & Discussion: The angle of repose for all the batches prepared. The values were found to be in the range of 30.46 to 36.45, which indicates good flow property for the powder blend according to the USP. The bulk density and tapped density for all the batches varied from 0.49 to 0.54 g/mL and 0.66 to 0.73, respectively. Carr’s index values were found to be in the range of 23.33 to 25.88, which is satisfactory for the powders as well as implies that the blends have good compressibility. Hausner ratio values obtained were in the range of 1.22 to 1.36, which shows a passable flow property for the powder blend based on the USP. The results for tablet thickness and height for all batches was found to range from 4.45 to 4.72 mm and 3.67 to 3.69 mm, respectively. Hardness or breaking force of tablets for all batches was found to range from 32.8 to 36.2 N. Tablet formulations must show good mechanical strength with sufficient hardness in order to handle shipping and transportation. Friability values for all the formulations were found to be in the range of 0.22 % to 0.30 %. Conclusion: Orally disintegrating tablets were compressed in order to have sufficient mechanical strength and integrity to withstand handling, shipping and transportation. The formulation was shown to have a rapid disintegration time that complied with the USP (less than one minute). The data obtained from the stability studies indicated that the orally disintegrating mini-tablets of MTH were stable under different environmental storage conditions. Keywords: Formulation & Development, Fast Dissolving Tablet, Metoclopramide, Anti-Emetic Drug, Oral Disintegrating Tablet


Agriculture ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 545
Author(s):  
Grzegorz P. Łysiak ◽  
Krzysztof Rutkowski ◽  
Dorota Walkowiak-Tomczak

Late pear cultivars, such as ‘Conference’, can be stored for a long period if kept in good storage conditions. A three-year study (2011–2013) compared the impact of six-month storage using four technologies—normal atmosphere, normal atmosphere + 1-methylcyclopropene (1-MCP), controlled atmosphere, and controlled atmosphere + 1-MCP—on the quality parameters of ‘Conference’ pears, such as mass loss, firmness, total soluble solids, acidity, antioxidant capacity, and the incidence of diseases and disorders. Additionally, the study analysed different storage conditions in terms of profitability, based on the market prices for pears in the seasons during which the pears were stored. The storage conditions had a very strong influence on the fruit quality parameters, and were found to affect most visibly the mass loss and the incidence of postharvest diseases and disorders. The storage of ‘Conference’ pears for 180 days in normal atmosphere is not economically viable, even if the fruit is subjected to 1-MCP treatment; at the same time, it is profitable to store ‘Conference’ pears in controlled atmosphere for the same period, no matter whether 1-MCP was applied or not.


Foods ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 1405
Author(s):  
Nima Hematyar ◽  
Jan Mraz ◽  
Vlastimil Stejskal ◽  
Sabine Sampels ◽  
Zuzana Linhartová ◽  
...  

The current knowledge on how different Eurasian perch rearing systems impact the final fillet quality is scant. Therefore, two domestic storage conditions were investigated—10 months frozen (-20 °C) and 12 days refrigerated (+4 °C) storage conditions—in order to determine (i) how the choice of rearing system affects fillets quality during different processing conditions and (ii) if oxidative changes and other quality parameters were interactive. For the proposed idea, proteome analysis, oxidative changes, and some quality parameters were considered in this study. Sodium dodecyl-sulfate polyacrylamide gel electrophoresis (SDS-PAGE) indicated a higher loss of protein in the frozen fillets from ponds (PF) than the fillets from recirculating aquaculture systems (RAS) (RF). Western blot showed a higher protein carbonyls level in RF compared to PF, which was confirmed by the total protein carbonyls during frozen storage. PF indicated less liquid loss, hardness, and oxidation progress than RF in both storage conditions. The biogenic amines index (BAI) in the fillets from either origin showed acceptable levels during storage at +4 °C. Furthermore, the n-3/n-6 ratio was similar for both fillets. The deterioration of fillets during frozen storage was mainly caused by formation of ice crystals followed by protein oxidation, while protein oxidation was the main concern during refrigerated storage confirmed by principal component analysis (PCA) analysis.


Agriculture ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 247
Author(s):  
Aida Albu ◽  
Cristina-Gabriela Radu-Rusu ◽  
Ioan Mircea Pop ◽  
Gabriela Frunza ◽  
Gherasim Nacu

Romania is known among the main European honey producers, due to the variety of landforms as well as the diversity of the flora. Thirty-four honey samples of the acacia, linden and multifloral types, produced in eastern Romania and collected during 2013–2018, were physico-chemically analyzed using methods provided by the national and EU standards. The results of water-insoluble solids, color and refractive index were found to be 0.023–0.131%, 0.3–76.4 mm Pfund and 1.485–1.499, respectively. The moisture content ranged between 15.20% and 20.77%, solid substances content ranged between 79.23% and 84.80% and total soluble substances content ranged between 77.83 °Brix and 83.26 °Brix. The obtained values of specific gravity were from 1.414 to 1.450 g/cm3, pH ranged from 3.673 to 5.503 and free acidity ranged between 2.4 meq and 50 meq kg−1. The ash content and the electrical conductivity varied between 0.030 and 0.543% and 130 and 679 µS cm−1, respectively. Pearsonʹs correlation analysis showed an intense association of the ash content with electrical conductivity (r = 0.81). Our findings reveal the qualitative level of Romanian honey and the variation in quality parameters due to factors such as geographical region, climatic conditions, botanical origin and handling or storage conditions.


Author(s):  
LUSI NURDIANTI ◽  
IYAN SOPYAN ◽  
TAOFIK RUSDIANA

Objective: The present study was conducted to formulate and characterize the thin film containing astaxanthin nanoemulsion (TF-ASN) using Hydroxypropylmethyl Cellulose (HPMC) polymer as a film matrix system. The stability studies in different storage conditions were also performed. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using self-nanoemulsifying method, followed by incorporation into the HPMC matrix system by solvent casting method to forming TF-ASN. Evaluation of TF-ASN was performed by physical and mechanical characterizations. Stability study was carried out in both of accelerated (temperature of 40±2 °C/75±5% RH) and non-accelerated (at ambient temperature) conditions. Assay of astaxanthin in individual TF-ASN was determined compared to pure astaxanthin. Results: TF-ASN had good physical and mechanical characteristics that suitable for intraoral administration. Conclusion: For the study of stability under different storage conditions, it was proven that nanoemulsion form was packed in a HPMC matrix could enhance the stability of the astaxanthin.


2019 ◽  
Vol 11 (2) ◽  
pp. 315-320
Author(s):  
Monika Chauhan ◽  
N S Thakur ◽  
Abhimanyu Thakur

Wild prickly pear (Opuntia dillenii Haw.) is one of the wild fruit with great importance because of its high antioxidants, colour pigments and other quality parameters besides its medicinal properties. In India, there are only a limited number of reports pertaining to utilization of this fruit which further lack the development of value added novel products. So, the present studies were carried out for the development of spiced squash or appetizer from wild prickly pear fruit and its quality evaluation during storage. Different combinations of fruit juice (25, 30, 35 and 40 %) and sugar syrup (40 and 45 °B) were tried to standardize a proper combination for appetizer. The appetizer prepared by using the best recipe with 35 % juice, 45 °B TSS (Total soluble solids) and 1.20 % acidity was packed in two packaging materials viz. glass and PET (Polyethylene terephthalate) bottles which were further stored for six months under ambient and refrigerated temperature conditions. Appetizer packed in glass as well as in PET packaging material can be stored successfully for a period of six months under both the temperature conditions. However, various quality parameters of appetizer were retained higher in glass bottles stored under refrigerated storage conditions.


2020 ◽  
pp. 1-12
Author(s):  
C. El Hajj Assaf ◽  
N. De Clercq ◽  
E. De Paepe ◽  
G. Vlaemynck ◽  
E. Van Coillie ◽  
...  

Patulin (PAT), a mycotoxin mainly produced by Penicillium expansum, is of high concern with regard to human food safety. This study examined the stability of PAT in artificially contaminated cloudy apple juice (CAJ) produced on a semi-industrial scale using an innovative technology allowing degassing and pressing under low-oxygen conditions (VaculIQ 1000). The effects of adding ascorbic acid (AA), degassing during production and storing in the dark at 20 °C on the PAT concentration were studied, as well as possible degradation and reaction products formed. The highest PAT degradation (50%) was observed for flash-pasteurised juice with AA added, produced under low-oxygen conditions and degassed and stored for 14 days at 20 °C in the dark in aluminium laminate aseptic bags. Juices produced showed no significant differences in the quality parameters measured and did not show significant formation of reaction products. Further research needs to be focused on the fate of PAT in CAJ produced on an industrial level with and without addition of AA.


2019 ◽  
Vol 62 (3) ◽  
pp. 661-671 ◽  
Author(s):  
Jia Wu ◽  
Xiangyang Lin ◽  
Shengnan Lin ◽  
Paul Chen ◽  
Guangwei Huang ◽  
...  

Abstract. The effects of packaging and storage conditions on the moisture content and instrumental and sensory textural properties of raw and salty light roasted (SLR) California almonds were studied under different storage conditions. The controlled combinations included low, medium, and high temperatures and low and high relative humidity (RH). Almond samples were packaged in cartons or polyethylene (PE) bags with and without vacuum. Both absorption and desorption of moisture by almonds were observed during storage and were dependent on the packaging and storage conditions. In general, gradual changes were observed for samples with PE and vacuum PE packaging in most of the storage conditions, while the samples packed in cartons showed more dramatic changes because these unprotected samples were more vulnerable to seasonal changes in humidity. The SLR almonds showed consistent moisture gains, while the raw almonds tended to lose moisture content in most of the storage conditions. This may be attributed to the low initial moisture content of the SLR samples. All raw samples packed in cartons became softer over time. The softening tended to be enhanced by high storage humidity and temperature. The raw almonds packaged in PE bags were firmer than those packed in cartons but also became softer over time. The firmness of the SLR samples was generally lower than that of raw samples, probably because roasting reduced the density and mechanical strength of the kernels. The firmness of PE packaged SLR samples increased in uncontrolled storage conditions and in higher storage temperature and humidity conditions but decreased slightly in lower temperature and humidity conditions. Vacuum packaging did not affect the firmness much. Using PE packaging and maintaining the RH below 50% and the temperature below 25°C are effective in stabilizing both raw and processed almonds. Keywords: Almond, Firmness, Nonpareil, Packaging, Relative humidity, Sensory, Storage, Temperature, Texture.


Sign in / Sign up

Export Citation Format

Share Document