scholarly journals Preparation and Evaluation of Extemporaneously Compounded Aspirin Capsules from Crushed Aspirin Tablets

2021 ◽  
pp. 221-228
Author(s):  
Iman M. Alfagih ◽  
Lama S. Aljaliel
Keyword(s):  
Quality Control ◽  
Relative Humidity ◽  
Significant Risk ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Uniformity Test ◽  
Clinical Consequences ◽  
Extemporaneous Preparation ◽  
Preparation And Evaluation ◽  
States Pharmacopeia

Aims: Extemporaneous preparations of medications might bring about technical and clinical consequences due to formulation failures. Therefore, all such prepared formulas should undergo valid and reliable procedures supported by solid data. Otherwise, patients can experience significant risk due to microbial contamination or physical or chemical changes during the preparation process. Thus, effective extemporaneous preparation relies on correct calculations to avoid extra and serious harm. Therefore, because 50-mg aspirin capsules are not available in Saudi Arabia, this study aimed to formulate 50-mg capsules from available 100-mg aspirin tablets. Methodology: Quality control tests of the preparations were carried out at the time of preparation and after one month of storage at 25 °C and at 40 °C and 75% relative humidity. All tests were carried out according to the British and United States pharmacopeia monograph of aspirin. Results: The drug content assay and uniformity test indicated that the aspirin capsules were within the pharmacopeial limits. The disintegration time for all aspirin capsules was within the pharmacopeial limits of 30 minutes. The aspirin release profile showed that approximately 90% of the aspirin dissolved after 10 minutes. Conclusion: The results indicated that the extemporaneous preparation of ASA capsules complied with the quality control tests for freshly prepared capsules and after one month of storage at room temperature and at 40 °C and 75% relative humidity. The dissolution profile of these capsules indicates immediate and high release of ASA, which is essential to ensure the required absorption. This study is of great importance for patients who need to take this dose of ASA. Pharmacists can prepare good-quality capsules with the desired ASA content using a 100-mg ASA tablet as a source of the active ingredient.

scholarly journals In-vitro comparative evaluation of quality control parameters between paracetamol and paracetamol/caffeine tablets available in Bangladesh

2012 ◽  
Vol 1 (5) ◽  
pp. 103-109 ◽  
Author(s):  
Palash Karmakar ◽  
Md Golam Kibria
Keyword(s):  
Quality Control ◽  
Pharmaceutical Journal ◽  
Dissolution Profile ◽  
Control Parameters ◽  
Disintegration Time ◽  
Weight Variation ◽  
Quality Control Parameters ◽  
Standard Quality ◽  
Tablet Hardness

Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. The study was conducted to assess the comparative in-vitro quality control parameters through the evaluation of weight variation, hardness, friability, disintegration time and dissolution profile between the commercially available tablet brands of paraceta-mol and paracetamol/caffeine combination in Bangladesh. Tablets of five top level manufacturers those have both of the formulations were evaluated in two groups. Both similarities and dissimilarities were found between the groups. All tablets either paracetamol (1.07 to 2.14%) or paracetamol/caffeine (0.98 to 2.09%) showed acceptable weight variation and friability (below 1%). Formulations were somewhat different in their hardness, disintegration time and dissolution profile. All tablets of paracetamol/caffeine were found harder than paracetamol tablets of the same manufacturer. 1 out of 5 for paracetamol and 3 out of 5 for paracetamol/caffeine tablets exceeded the limit of tablet hardness or crushing strength. The disintegration time in 0.1N HCl of paracetamol tablet brands (24 seconds to 4 minutes 52 seconds) were less than the paracetamol/caffeine (6 minutes 33 seconds to 17 minutes 43 seconds) brands. On the other hand in phosphate buffer, pH 7.4, paracetamol/caffeine tablets dissolved quickly and showed better release profile than tablets containing only paracetamol. It can be concluded that standard quality control parameters always should be maintained not only for paracetamol or its combination but also for all kinds of medicine for getting better drug products.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10282International Current Pharmaceutical Journal 2012, 1(5): 103-109

scholarly journals In vitro Comparative Quality Evaluation of Formulated and Marketed Losartan Potassium 25 Mg Tablets

2021 ◽  
pp. 239-245
Author(s):  
Md. Emran Hossain ◽  
Sukria Hossain ◽  
Md. Shahin Sarker ◽  
Mst. Mahfuza Rahman ◽  
Mir Imam Ibne Wahed
Keyword(s):  
Quality Control ◽  
Drug Product ◽  
Qualitative Evaluation ◽  
Quality Standard ◽  
Losartan Potassium ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation

Background: The outcome of the drug therapy depends largely on the quality of the drug product. The lower quality of the drug product can be the reason for therapeutic failure. The present study was designed to evaluate the quality standard of Losartan Potassium tablet brands available in Bangladesh market to get an idea of quality standard of drug product people consuming in this country. Materials and methods: Three brands of losartan potassium were chosen randomly. Tablets of each brand were collected from individual retail outlets to gauge the qualitative evaluation and compare them by in-vitro drug release study. They were subjected to various quality control tests to measure the hardness, thickness, weight variation, friability, disintegration time, potency, stability, and dissolution profile. All these tests were performed according to the U.S. Pharmacopeia (USP) specification. Researchers further formulated a batch of tablet of Losartan Potassium and compared them with the existing brands. The formulation was prepared by optimizing the existing one available in the USP. Test results of the existing brands were taken into consideration during the optimization of the formulation. Results and discussion: Two brands passed the weight variation test, while one brand exceeded the range (±5%). The potency was determined instantly and 15 days after keeping the tablets in a stability chamber at 75% humidity and 60oC temperature. The potency of two brands degraded below the lower limit specified by the USP, while that of the remaining one was within the limits. Results of other tests were within the specified limits. Tablets prepared in the lab using an optimized formulation showed a better dissolution rate than the existing brands. Conclusion: Some of the brands failed to meet the desired quality, so the quality control system of that companies should be upgraded and a proper monitoring system should be developed by the drug administration.

Post–market In vitro Equivalency Evaluation of Paracetamol Tablets in Kedah, Malaysia

2011 ◽  
Vol 4 (2) ◽  
pp. 1403-1407
Author(s):  
Chandrasekaran A R ◽  
Chen Yi Han ◽  
Alex Chin Yang Chung ◽  
Lim Wei Cheang ◽  
Low Sing Ping
Keyword(s):  
United States ◽  
Quality Control ◽  
United States Pharmacopeia ◽  
Disintegration Time ◽  
British Pharmacopoeia ◽  
Time Profiles ◽  
Post Market ◽  
Tablet Hardness ◽  
States Pharmacopeia

 Six brands of paracetamol (acetaminophen) 500 mg tablets have been evaluated using specific quality control tests for uniformity of weight, hardness, friability, content, disintegration and dissolution with the aim to assess its bioequivalence. The results obtained have been discussed in details using monographs in United States Pharmacopeia and British Pharmacopoeia. In conclusion, despite some apparent minor differences in tablet hardness and disintegration time profiles, the dissolution characteristics of various paracetamol tablets appears to be similar and not significantly different from various manufacturers.  

A Comparative Study of Quality on Conventional Paracetamol Tablets Available in Pakistan

2016 ◽  
Vol 2 (3) ◽  
pp. 205-210
Author(s):  
Muhammad Saquib Qureshi ◽  
Gul Rukh ◽  
Pooja Deepak Kirplani ◽  
Asiya Farheen ◽  
Madhia Hamid
Keyword(s):  
United States ◽  
Quality Control ◽  
Physical Characteristics ◽  
United States Pharmacopeia ◽  
Disintegration Time ◽  
Over The Counter ◽  
Quality Control Laboratory ◽  
Weight Variation ◽  
Label Claim ◽  
States Pharmacopeia

Background: Paracetamol (Acetaminophen) is used as over the counter (OTC) medicine for relief of pain and fever. Paracetamol is available in different brands in Pakistani pharmaceutical market. Objective: To assure the quality control parameters of different brands of paracetamol in Pakistan. Methodology: The pharmaceutical and chemical equivalence of five brands of paracetamol were assessed. For ethical concerns, the brands were coded as PRC-1, PRC-2, PRC-3, PRC-4 and PRC-5. Study was conducted in quality control laboratory of Adamjee Pharmaceuticals during December 2015 to February2016. Identification, physical characteristics, thickness, diameter, weight variation, hardness, disintegration time, percent label claim (Assay) and dissolution rate were calculated for each brand using monographs of British Pharmacopeia and United States Pharmacopeia. Results: Identification, physical characteristics, thickness, diameter, weight variation, hardness, and disintegration time, percent label claim (Assay), and dissolution ratewere calculated for each brand and the results were within the specifications provided by British Pharmacopeia and United States Pharmacopeia. Conclusion: All the brands selected in the study showed results within the limits assuring quality standards of manufacturing.

scholarly journals 3DP Printing of Oral Solid Formulations: A Systematic Review

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 358 ◽  
Author(s):  
Chiara R. M. Brambilla ◽  
Ogochukwu Lilian Okafor-Muo ◽  
Hany Hassanin ◽  
Amr ElShaer
Keyword(s):  
Systematic Review ◽  
Data Extraction ◽  
New Technology ◽  
Three Dimensional ◽  
Extraction Process ◽  
Carcinogenic Risk ◽  
Drug Dissolution ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Advantages And Disadvantages

Three-dimensional (3D) printing is a recent technology, which gives the possibility to manufacture personalised dosage forms and it has a broad range of applications. One of the most developed, it is the manufacture of oral solid dosage and the four 3DP techniques which have been more used for their manufacture are FDM, inkjet 3DP, SLA and SLS. This systematic review is carried out to statistically analyze the current 3DP techniques employed in manufacturing oral solid formulations and assess the recent trends of this new technology. The work has been organised into four steps, (1) screening of the articles, definition of the inclusion and exclusion criteria and classification of the articles in the two main groups (included/excluded); (2) quantification and characterisation of the included articles; (3) evaluation of the validity of data and data extraction process; (4) data analysis, discussion, and conclusion to define which technique offers the best properties to be applied in the manufacture of oral solid formulations. It has been observed that with SLS 3DP technique, all the characterisation tests required by the BP (drug content, drug dissolution profile, hardness, friability, disintegration time and uniformity of weight) have been performed in the majority of articles, except for the friability test. However, it is not possible to define which of the four 3DP techniques is the most suitable for the manufacture of oral solid formulations, because the selection is affected by different parameters, such as the type of formulation, the physical-mechanical properties to achieve. Moreover, each technique has its specific advantages and disadvantages, such as for FDM the biggest challenge is the degradation of the drug, due to high printing temperature process or for SLA is the toxicity of the carcinogenic risk of the photopolymerising material.

Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets

2021 ◽  
pp. 255-258
Author(s):  
Bhavana Habib ◽  
Jyoti Mittha
Keyword(s):  
Quality Control ◽  
Quality Evaluation ◽  
Indian Market ◽  
Disintegration Time ◽  
Innovator Product ◽  
Drug Content ◽  
Weight Variation ◽  
Generic Products

The aim of the present study was the evaluation and comparison between four different Metformin and Vildagliptin tablets which are commercially available in Indian market. These tablets were assessed for various pharmacopoeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (three generic and an innovator). These results show that the tested generic products were biopharmaceutically similar to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.

Physicochemical Evaluation of Brands of Amlodipine Besylate Tablets.

2020 ◽  
Vol 1 (5) ◽  
pp. 24-33
Author(s):  
C.A. Anyanwu-Ndulewe ◽  
◽  
L.E. Mogbolu ◽  
M.A. Oladunni ◽  
A.A. Adepoju-Bello
Keyword(s):  
Hardness Test ◽  
Drug Market ◽  
The United States ◽  
Financial Strain ◽  
Average Weight ◽  
Dissolution Profile ◽  
Amlodipine Besylate ◽  
Disintegration Time ◽  
Physicochemical Evaluation ◽  
Dissolution Efficiency

Background: Hypertension is a chronic condition, and the cost of filling prescriptions has a potential of putting a financial strain on patients, hence the need for lower priced but bioequivalent generics. The Nigerian drug market is awash with generics of Amlodipine besylate, a first line drug in the treatment of hypertension, therefore, any prescribed alternative must be bioequivalent to the originator. Objectives: This study assessed the physicochemical properties of some brands in order to predict pharmaceutical and bioequivalence and invariably, the interchangeability with the innovator brand. Methods: Compendial parameters of average weight, friability, disintegration, drug content and dissolution profile of ten generic brands were evaluated using the United States Pharmacopeia (USP) as well as the non-official hardness test. Results: Two brands failed the test for hardness, while still keeping to the stipulated friability limit. All the brands met the required disintegration time, irrespective of the discordance of some brands in the breaking force and friability values. All brands were found to contain between 92.00 and 103.57% (w/w) of Amlodipine besylate. Two brands failed to achieve ≥75% dissolution expected at 30 minutes and this was reflected in the low f2 values of 35.06% and 28.73%. The dissolution curves displayed a similarity for two brands, which was also corroborated by the high percentage dissolution efficiency (DE) of 92.00%, as well as the f1 and f2 values, compared to the innovator brand. Conclusion: Although the parameters used may predict therapeutic equivalence, interchangeability with the comparator brand is subject to relevant bioequivalence studies.

Stability of extemporaneously prepared rosuvastatin oral suspension

2017 ◽  
Vol 74 (19) ◽  
pp. 1579-1583 ◽  
Author(s):  
Abdel Naser Zaid ◽  
Rania Shtayah ◽  
Ayman Qadumi ◽  
Mashour Ghanem ◽  
Rawan Qedan ◽  
...  
Keyword(s):  
Relative Humidity ◽  
High Performance ◽  
Room Temperature ◽  
Microbial Contamination ◽  
Active Pharmaceutical Ingredient ◽  
Storage Conditions ◽  
Dissolution Profile ◽  
Stability Studies ◽  
Organoleptic Properties ◽  
The Stability

Abstract Purpose The stability of an extemporaneously prepared rosuvastatin suspension stored over 30 days under various storage conditions was evaluated. Methods Rosuvastatin suspension was extemporaneously prepared using commercial rosuvastatin tablets as the source of active pharmaceutical ingredient. The organoleptic properties, dissolution profile, and stability of the formulation were investigated. For the stability studies, samples of the suspension were stored under 2 storage conditions, room temperature (25 °C and 60% relative humidity) and accelerated stability chambers (40 °C and 75% relative humidity). Viscosity, pH, organoleptic properties, and microbial contamination were evaluated according to the approved specifications. High-performance liquid chromatography was used for the analysis and quantification of rosuvastatin in selected samples. Microbiological investigations were also conducted. Results The prepared suspension showed acceptable organoleptic properties. It showed complete release of rosuvastatin within 15 minutes. The pH of the suspension was 9.8, which remained unchanged during the stability studies. The microbiological investigations demonstrated that the preparation was free of any microbial contamination. In addition, the suspension showed stability within at least the period of use of a 100-mL rosuvastatin bottle. Conclusion Extemporaneously prepared rosuvastatin 20-mg/mL suspension was stable for 30 days when stored at room temperature.

scholarly journals Enhancement of Solubility and Improvement of Dissolution Rate of Atorvastatin Calcium Prepared as Nanosuspension

2019 ◽  
Vol 28 (2) ◽  
pp. 46-57
Author(s):  
Ahmed H. Ali ◽  
Shaimaa N. Abd-Alhammid
Keyword(s):  
Particle Size ◽  
Water Soluble ◽  
In Vitro Dissolution ◽  
Precipitation Method ◽  
Size Analysis ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Atorvastatin Calcium ◽  
Freeze Dried

       Atorvastatin have problem of very slightly aqueous solubility (0.1-1 mg/ml). Nano-suspension is used to enhance it’s of solubility and dissolution profile. The aim of this study is to formulate Atorvastatin as a nano-suspension to enhance its solubility due to increased surface area of exposed for dissolution medium, according to Noyes-Whitney equation.         Thirty one formulae were prepared to evaluate the effect of ; Type of polymer, polymer: drug ratio, speed of homogenization, temperature of preparation and inclusion of co-stabilizer in addition to the primary one; using solvent-anti-solvent precipitation method under high power of ultra-sonication. In this study five types of stabilizers (TPGS, PVP K30, HPMC E5, HPMC E15, and Tween80) were used in three different concentrations 1:1, 1:0.75 and 1:0.5 for preparing of formulations. At the same time, tween80 and sodium lauryl sulphate have been added as a co-stabilizer.          Atorvastatin nano-suspensions were evaluated for particle size, PDI, zeta potential, crystal form and surface morphology. Finally, results of particle size analysis revealed reduced nano-particulate size to 81nm for optimized formula F18 with the enhancement of in-vitro dissolution profile up to 90% compared to 44% percentage cumulative release for the reference Atorvastatin calcium powder in 6.8 phosphate buffer media. Furthermore, saturation solubility of freeze dried Nano suspension showed 3.3, 3.8, and 3.7 folds increments in distilled water, 0.1N Hcl and 6.8 phosphate buffers, respectively. Later, freeze dried powder formulated as hard gelatin capsules and evaluated according to the USP specifications of the drug content and the disintegration time.        As a conclusion; formulation of poorly water soluble Atorvastatin calcium as nano suspension significantly improved the dissolution of the drug and enhances its solubility.

scholarly journals Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Rajaa F. Hussein ◽  
Reem AlSwayeh ◽  
Syed N. Alvi
Keyword(s):  
Quality Evaluation ◽  
Diclofenac Sodium ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
United States Pharmacopoeia ◽  
Weight Variation ◽  
Tablet Formulations ◽  
Enteric Coated

Abstract Objective To evaluate in vitro quality of enteric-coated 50 mg diclofenac sodium tablet formulations on Saudi market. Results A reference and seven generic (G1-7) formulations were commercially available in December 2019/January 2020 and were assessed within 25–75% of manufacture-expiration period. Weight variation (range as% difference from mean, n = 20), active substance content (ASC, mean (SD) as% difference from label, n = 20), hardness (mean (SD), n = 10), and friability (% weight loss, n = 20) were 97–103%, 102.0% (3.4%), 15.4 (1.1) kg, and 0.24%, respectively, for the reference. For G2-7, they were ≤ ±5%, 98.6% (4.0%) to 109.9% (1.8%), 11.9 (0.9) to 18.3 (0.8) kg, and ≤ 0.00 to 0.75%, respectively. G1 ASC, hardness, and friability were 111.3% (1.7%), 20.1 (1.7) kg, and 1.10%, respectively. Disintegration time (n = 6) and dissolution profile (n = 8) were also determined. No formulation disintegrated or released ˃ 0.1% of label ASC in 0.1 N HCl for 2 h. The reference disintegrated in 15:00 min:seconds and released a mean (range) of 100% (99–103%) of label ASC by 45 min in phosphate buffer (pH = 6.8). G1-7 disintegrated in 8:53 to 20:37 min:seconds and released 81% (69–90%) (G1) to 109%. Except for borderline performance of G1, all formulations passed in vitro quality tests according to United States Pharmacopoeia.

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