Friability Test Research Articles

Assessment of Quality Control parameters under Accelerated Stability Conditions for Manasamitra Vatakam; A Herbo Mineral Formulation

Accelerated Stability Studies predicts the stability data and significantly explains the drug decision process. In the present study, Manasamitra Vatakam, a Herbo mineral formulation was subjected to stability conditions at 40°C ± 2°C /75%± 5% RH for 06 months. Control and stability samples were determined for parameters like Weight variation, Moisture content, Marker content determination, and Disintegration test, Dissolution study with different mediums, Friability and Hardness test. The phytomarker analysis showed decrease assay value for β-sitosterol, Vitexin, Kampferol and Withaferin. The dissolution studies were performed for the major biomarker Berberine in 0.1N HCl, pH 4.5 acetate and pH 6.8 phosphate buffer in which pH 6.8 buffer showed maximum release of 66.82% at 04 hours. The other Quality control parameters showed minimal difference under acceptance criteria. The study explains the need of stability analysis in polyherbal formulations and developed method can be used for routine analytical studies in various formulation containing berberine. Keywords: Berberine, HPLC, Manasamitra Vatakam, Quality Control, Stability.

Post-marketing quality surveillance of selected antibacterial agents marketed in porous borders; the case of Ethiopia-Sudan-Eritrea border.

The presence of poor-quality medicines is becoming a public health threat in many parts of the world, particularly in developing countries. Antibiotics are among the most common anti-infective medicines that are highly prone to this problem. The purpose of this study was to assess the quality of selected antibacterials that are marketed in Setit Humera and West Gondar Zones, North West Ethiopia, which are located on the Ethiopian side of the Ethiopia-Sudan-Eritrea border. Seventy-one samples of the four antibacterial medicines (Ciprofloxacin, Norfloxacin, Amoxycillin, and Amoxycillin clavullanate combination) were collected from six sites in Setit Humera and West Gondar Zones, North West Ethiopia. A mystery shopping system was used for sample collection. Visual inspections and confirmation of the registration status were carried out using the joint WHO/FIP/USP checklist and the Ethiopian Food and Drug Authority's (EFDA's) Electronic Regulatory Information System (eRIS), respectively. Then Pharmacopeial methods (USP, BP) were employed to assess the physicochemical quality parameters. During the period of our data collection, the application status for registration in the eRIS system was checked. From 71 samples, 25.35% (18/71) were not registered, and 15.49% (11/71) were registered, but the license period had expired. Some samples (12.06% (17/71)) did not meet the visual inspection criteria. The physicochemical evaluation showed that all the samples studied met the quality specifications for the identification and hardness tests. However, concerning assay, dissolution, uniformity of dosage units, disintegration, and friability test parameters, 27.49% (23/71), 16.9% (12/71), and 14.08% (10/71), 2.82% (2/71) and 8.57% (3/35) of samples were found to be substandard, respectively. Overall, 56.33% (40/71) of the samples tested were of poor quality, failing to meet any one or more of the assessed parameters in this study. The study indicated that poor-quality antibacterial medicines are circulating in the study sites. Therefore, even if the area was affected by conflict at the time of the study, the regulatory bodies should focus on enforcing the necessary measures by collaborating with the regional and national regulatory medicine agencies to ensure that the antibacterial medicines available meet the required mandatory minimum standards.

In vitro comparative quality assessment of different brands of hydrochlorothiazide tablets marketed in Northeast Ethiopia

BackgroundThis study aimed to comparatively evaluate the quality and physicochemical bioequivalence of commercially available brands of hydrochlorothiazide (HCT) tablets in community pharmacies in Dessie town, Northeast Ethiopia.MethodsExperimental cross-sectional study design was applied using pharmacopeia and non-pharmacopeia methods. The difference (f1) and similarity (f2) factors were calculated to assess the in vitro bioequivalence of generic products with the comparator.ResultThe study results revealed that all investigated brands contained the required active pharmaceutical ingredients (APIs). The friability test results were concordant with the United States Pharmacopeia (USP) (<1%) for eight brands; however, brand NF3 (1.36%) failed to pass the specification limit. The hardness levels of the brands NF3 (24.20 ± 7.32 N), NF5 (32.19 ± 4.78 N), and NF9 (35.02 ± 3.12 N) were below the specification limit (39.23 N, USP 2019). The weight variation results of all generic products complied with the USP specification requirement. In the quantitative assay results, the minimum and maximum API contents were 97.4 ± 0.02 (NF6) and 105.8 ± 0.02 (NF8), respectively, which are within the limit specified by the USP (90%–110%). Similarly, all samples met the disintegration time limit (i.e., ≤30 min) and drug-releasing tolerance limit (API released more than 60% within 60 min) requirements. The f2 values were >50, and the f1 values were <15 for all sampled brands.ConclusionThe majority of the sampled brands of HCT tablets met the quality requirements as per USP official test specifications. From the similarity and difference factor values, all studied brands were shown to be equivalent.

Quality of medicines for Cardio-Vascular Diseases (CVDs) in the Ethiopian border with Kenya: The case of enalapril maleate and furosemide tablet quality in Borena and Gedeo zones.

Hypertension (HTN), a cardiovascular disease (CV), is a major public health challenge. Therefore, the quality of drugs used to treat it has become a major concern. Enalapril and furosemide are among the drugs prescribed to manage hypertension. Hence, this study is aimed at evaluating the quality of different brands of enalapril and furosemide tablets available in the Gedeo and Borena zones, southern Ethiopia. Thirteen generic brands of enalapril maleate (5 mg) and furosemide (40 mg) tablets were evaluated for visual defects, in vitro dissolution test, weight variations, friability, hardness, and disintegration tests. The analysis of active pharmaceutical ingredient (API) content was performed by high performance liquid chromatography (HPLC). Out of 55 samples, 7 (12.73%) failed to comply with the criteria for visual inspection; otherwise, all samples passed the identification test. Except for one brand of each of enalapril maleate and furosemide, all passed the dissolution test. The assay value showed that all enalapril maleate samples were within the limits of United States Pharmacopoeia (USP), 2020. Additionally, except for two batches, all furosemide samples were within the USP and British Pharmacopoeia (BP), 2020 standards. Out of 55 samples, 8% (2/25) and 6.67% (2/30) of enalapril maleate and furosemide tablets failed the uniformity of dosage units test per the USP-2020, respectively. All samples passed the disintegration test, and selected furosemide samples passed the microbial limit tests. However, 36% (9/25) and 20% (6/30) of enalapril maleate and furosemide samples failed to pass hardness test. Generally, from the total samples, 50.91% (28/55) were substandard (did not meet the specifications failing any one or more parameters assessed). The studied drugs circulating in the market did not meet some of the needed quality specifications. This could have brought a risk of reduced efficacy due to the distribution of poor quality medicines in the area.

Stability of clozapine tablets repackaged in dose administration aids using repackaging machines

BackgroundThe use of dose administration aids in automated ward dispensing devices requires the repackaging of medications, which may impact their stability compared with the original manufacturer’s packaging.ObjectivesThis study aimed to...

A Comparative Quality Control Study of Brand and Generic Amlodipine Tablets by In-Vitro Testing

The objective of this study was to conduct in-vitro quality control testing of brand versus generics of Amlodipine tablets. One brand and two generic Amlodipine tablets were used in the study. In the terms of weight variation, Brand, Generic A and Generic B have an above the mean weight limit variation of 2.15%, 2.23%, & 1.43% respectively. The lower mean weight limit variations are 1.85%, 1.92% & 1.23% respectively which are within the 7.5% standard limit of IP. Friability test shows that Brand, Generic A & Generic B have an average friability of 0.5%, 0.480% ,0.3% mass loss, which are within 1%. mass lost limit of IP. Hardness test shows that Brand, Generic A & Generic B have an average hardness of 0.9 kg/cm2, 2.3 kg/cm2 and 1 kg/cm2 respectively. The disintegration test shows that Brand, Generic A & Generic B fall within 15-minutes time interval segment with disintegration time determined 20 sec, 3 min, 2.5 min respectively. In terms of drug assay brand, Generic A & Generic B fall under IP limit of 90% to 110%. The Brand, Generic A & Generic B have a drug dissolution percentage of 101%, 104%, 104% respectively within 30 minutes sampling time interval. The QC tests results for amlodipine tablets show that Brand, Generic A and Generic B confirm to the IP standards.

Quality assessment of metformin hydrochloride tablets retailed in Lagos, Nigeria

Background: Metformin is a biguanide antihyperglycemic drug used with diet and exercise for glycemic control in type 2 diabetes mellitus.Objectives: This research aims to compare and analyze different metformin products to ascertain their critical quality parameters. The goal is to ensure that prescribed medicine effectively treats patients and protects the public.Materials and Methods: We evaluated the quality of ten metformin tablet brands in Lagos (Mushin and Surulere area) using official methods to assess weight, hardness, friability, disintegration time, and dissolution. Active ingredient content was also measured.Results: Out of all the tablets tested, only 10 % had weights outside of the official British Pharmacopoeia 2002 limits (not more than two tablets should deviate from ±5% and none of the tablets should deviate by ± I0). The hardness test was passed by all the tablets (A minimum hardness of 4 kgF is a pass), while 80 % passed the friability test (weight loss of ≤ 1 %w/w is a pass). Additionally, all film-coated tablets disintegrated within 30 minutes according to United States Pharmacopoeia/National Formulary 2003 (film-coated tablets disintegrate within 30 minutes). Ninety percent of the tablets passed the dissolution test (drug release within 60 minutes should be between 93 and 103 %) and 90 % of all brands examined passed the assay test for the active ingredient contents. The British Pharmacopoeia 2019 standard was used for the dissolution test.Conclusion: Routine pharmaceutical analysis is essential for the quality of pharmaceutical products and the safety of consumers.

ESTIMATING THE RELEASE EFFECT ON BSC-I DRUG BY USING A COMBINATION OF METHYLCELLULOSE AND EUDRAGIT® S-100 POLYMERS TO FORMULATE MINI-FLOATING TABLETS

The purpose of the current research was to prepare a delayed-release system of mini-tablets (gastroprokinetic drug). The model drug (itopride hydrochloride) was formulated with the combination of methylcellulose (free-flowing agent) and Eudragit® S-100 (enteric coating agent) for delayed release. The research objective was to control the drug release in the stomach. The preparation of floating minitablets in three batches using different concentrations of polymers (methylcellulose in increasing order and Eudragit® S-100 remaining constant in two batches and the concentration decreased in the third batch) was utilized for the maintenance of the drug release pattern by evaluating the three batches for their weight variation, content uniformity, % drug release, thickness, hardness and friability tests. The selection of optimized formulation was based on the in vitro dissolution studies and floating lag time. As a result, Eudragit® S-100 showed a better-delayed release action. Formulation F2 gave better-delayed release (67.09 % for 360 minutes) and floating properties (1.34 minutes for lag time) in comparison to other batches i.e.; F1 and F3. The F3 results showed that the floating lag time (1.29 minutes) will decline, while methylcellulose concentration increases but Eudragit® S-100 concentration decreases, which reveals the enteric coating action of the Eudragit® S-100 polymer for delayed drug release in the studies.

Investigating the Presence of Falsified and Poor-Quality Fixed-Dose Combination Artemether-Lumefantrine Pharmaceutical Dosage Forms in Kumasi, Ghana.

Artemether-lumefantrine (AL) is a highly effective and commonly used Artemisinin-based Combination Therapy (ACT) for treating uncomplicated malaria caused by Plasmodium falciparum, including drug-resistant strains. However, ineffective regulatory systems in resource-limited settings can lead to the infiltration of poor-quality and counterfeit antimalarial medicines into the pharmaceutical supply chain, causing treatment failures, prolonged illness, and disease progression. The objective of the study was to assess the quality of selected brands of fixed-dose combination (FDC) AL tablets and suspensions marketed in Kumasi, Ghana. A total of fourteen brands of FDC AL medicines, comprising eight tablets and six suspensions were purchased from various retail pharmacy outlets in Kumasi, Ghana. All samples were subjected to thorough visual inspection as a quick means of checking quality through meticulous observation of the packaging or dosage form. The quality parameters of the tablets were determined using uniformity of weight, hardness, friability, and disintegration tests. Suspensions were assessed based on pH and compared with the British Pharmacopeia (BP) standard. The samples were then analyzed for drug content (assay) using reverse-phase high-performance liquid chromatography (RP-HPLC). All the tablet samples conformed to BP specification limits for uniformity of weight (deviation of less than ± 5%), hardness (4.0-10 kg/mm2), friability (<1%), and disintegration time (<15 minutes). The active pharmaceutical ingredients' quantitative assay demonstrated that all the tablets met the BP specifications (90-110%). The results of the pH studies showed that out of the six brands of suspension investigated, five (83.3%) were compliant with the official specification for pH, while one (16.7%) failed the requirement. Unlike the tablet brands, drug content analysis of the six suspensions showed that two (33.3%) were substandard. The artemether and lumefantrine contents in these failed suspensions were variable (artemether: 81.31%-116.76%; lumefantrine: 80.35%-99.71%). The study results indicate that most of the tested products met the required quality standards, demonstrating satisfactory drug content and other quality specifications. The presence of substandard drugs underscores the necessity for robust pharmacovigilance and surveillance systems to eliminate counterfeit and substandard drugs from the Ghanaian market.

Utilization and Evaluation of Rice Bran and Rice Bran Wax as a Tablet Lubricant.

The rice bran and rice bran wax of the KJ CMU107 rice strain were investigated as potential tablet lubricants in a directly compressed tablet formulation. Stabilized full-fatted rice bran (sFFRB), stabilized defatted rice bran (sDFRB), and rice bran wax (RBW) extracted and purified from crude rice bran oil (cRBO) were tested. Two commercial lubricants, including magnesium stearate (MGS) and hydrogenated cottonseed oil (HVO), were employed as the standards in the formulated mixtures, which contained spray-dried rice starch (SDRS) as a diluent. The tableting was carried out for each formulation, and the obtained tablets were physically and mechanically evaluated. Among the parameters investigated were the general appearance, ejection force, weight variation, hardness, friability, and disintegration time. The powder flow was also determined for each formulation. The results showed that the tablet ejection forces for all the lubricated formulations (58-259 N) were significantly lower than that of the non-lubricated control formulation (349 N). The use of sFFRB as a lubricant at 0.5-2.0% w/w could lower the ejection force up to 78%, but the hardness reduced so drastically that the formulations failed the friability test due to the chipping of the tablets' edges. Moreover, sDFRB performed significantly better as the use at 0.5-1.0% w/w in the formulation helped to lower the ejection forces by up to 80% while maintaining the changes in the tablet hardness within 10%. RBW functioned effectively as a tablet lubricant at a concentration of 0.5% w/w, yielding tablets with good strength comparable to standard HVO lubricant while helping to reduce the ejection force by 82%. In formulations with good lubrication, i.e., friability < 1%, the powder flow was improved, and the tablet disintegration times were within the same range as the control and HVO formulations. In conclusion, sDFRB displayed a lubricant property at concentrations between 0.5 and 1.0% w/w, with slightly negative effects on the tablet hardness. RBW from KJ CMU107 rice was an effective tablet lubricant at 0.5% w/w, with no effect on tablet hardness. Both materials can be further developed for use as commercial lubricants in direct compression.

Formulation and evaluation of floating tablet of nimesulide by direct compression method

Nimesulide has been used versatile on fever, pain, inflammation, rheumatoid arthritis, tendinitis, thrombophlebitis and trauma. Common drawbacks of conventional tablet dosage forms of nimesulide show an irritant effect on the stomach due to its weakly acidic nature along it has short duration of action leading to poor bioavailability. A Floating drug delivery system for Nimesulide leads to overcoming the problem related to an irritant on the stomach by avoiding direct contact with the mucosa. Thus, this study was designed and performed to formulate and evaluate the floating tablet of Nimesulide and determine the release pattern of the prepared formulation. Tablets were prepared by direct compression method using different polymers (HPMC, carbopol, and guar gum), either in an individual or in combination. The formulation blend was subjected to various pre-formulation and post-formulation studies including floating lag time, total floating time, hardness, friability, drug content, weight uniformity, and in-vitro dissolution. According to pre- pre-formulation study, the flow property was found to be good to passable. Similarly, all post-compression parameters of floating tablets were found to be within acceptable limits except the friability test of F1 and F2 formulations. The tablet’s floating lag time was determined to be in the range of 7-153.5 seconds, and the total floating time was in the range of 4-7 hrs. From the data of dissolution, carbopol showed a slower release of drugs than that of HPMC and guar gum. The use of carbopol as a floating polymer showed release of drugs from dosage form was 84.46% in 7 hrs and 99.10% in 3 hrs with the use of HPMC, 96.39% in 4 hrs with the use of guar gum. A combination of HPMC and guar gum released drugs in a slow release of drugs only for 3 hrs i.e. 98.02% in 3 hrs, the combination of carbopol and HPMC slowly released drugs for 6 hrs i.e. 90.43% in 6 hrs, and the combination of carbopol and guar gum showed maximum slow release of drugs for greater than 7 hrs i.e.74.16% in 7hrs. Hence, among all the formulations, F7 with the combination of carbopol and guar gum as polymer showed a maximum slowed release effect for greater than 7 hrs, which can be taken as the best batch.

PHYSICAL ASSESSMENT AND ATOMIC ABSORPTION SPECTROPHOTOMETRIC ANALYSIS OF CADMIUM AND LEAD IN TWENTY-FIVE BRANDS OF CIPROFLOXACIN TABLETS MARKETED IN LAGOS, NIGERIA.

Ciprofloxacin is a second-generation broad-spectrum antibiotic of the fluoroquinolone class, highly effective against many bacteria. Several brands of this drug class are marketed for public consumption; hence, it has placed the public in a confused state about the best brands with suitable physical characteristics and safe oral consumption. Additionally, the adverse effects of heavy metal accumulation in drugs for oral use have made it essential to quantify the amount of such heavy metals present. Evaluating the physical quality, elemental analysis identity, and concentration of cadmium and lead in twenty-five brands of ciprofloxacin tablets marketed in Lagos, Nigeria, is the aim of this study. The physical assessment of the tablets was then methodologically evaluated for these parameters; Uniformity of weight, Hardness, Friability, and Disintegration tests. Determining the amount of Cadmium and Lead with the Atomic Absorption Spectrophotometer (AAS) and evaluating using the Permitted Daily Exposure (PDE). Among all the brands of Ciprofloxacin tablets analyzed, 96 % passed the Uniformity of weight test, 52 % passed the Hardness test, 96 % passed the Friability test, and 96 % passed the disintegration test while 2 % passed the test according to the Permitted Daily Exposure (PDE) to Cadmium. 72 % passed the test according to the Permitted Daily Exposure (PDE) to Lead. The brands that passed the physical tests have good quality and correct physical characteristics. Cadmium and lead are of no benefit to humanity in the body and because they are not easily eliminated from the body, their buildup can put people at risk for mental retardation in children, dementia, kidney damage, nerve damage, infertility, high blood pressure, and cancer at high exposure levels. Keywords: Ciprofloxacin, Permitted Daily Exposure, Physical characteristics, Atomic Absorption Spectrophotometer, Cadmium, Lead

The Effect of PEG 4000 in Co-processed Excipient using Melt Granulation Method on the Physical Characteristics of Chitosan Tablets in Mangrove Crab Shells (Scylla serrata)

Mangrove Crab (Scylla serrata) is an animal that likes to be consumed but its shell waste is underutilized. The shell contains chitosan which has many benefits, one of which can lower cholesterol levels. The combination of 2 or more excipients is called co-processed excipients which are then continued into tablets by direct compression. The aim of the study was to find out whether chitosan could be formalized into coprocessed tablets (lactose, primogel, and PEG 4000 7.5% &amp; 15%) by direct compression method and the effect of differences in the characteristics of coprocessed and chitosan tablets with a ratio of PEG 4000 7.5% and 15 % as binder. The evaluation results showed that chitosan tablets fulfilled the requirements for the uniformity of weight, hardness, disintegration time (F1) tests, while they did not meet the requirements for the uniformity of tablet size, friability and disintegration times (F2) tests and the results of the coprocessing evaluation met specifications both F1 and F2, namely: particle size distribution, moisture content, flow rate, angle of repose (very good), compressibility index (adequate) and Hausner's ratio (very good). The evaluation results were then processed statistically using the SPSS application using the independent t-test method which showed that there was no significant difference in the effect of PEG 4000 7.5% and 15% as a binder on the characteristics of co-processed and chitosan tablets. Chitosan tablets from mangrove crab shells (Scylla serrata) cannot be formalized by direct compression with co-processing.

DEVELOPMENT OF CONTROLLED RELEASE FORMULATIONS OF DEXLANSOPRAZOLE TO IMPROVE BIOAVAILABILITY

The present work was aimed to development of controlled release formulations of Dexlansoprazole to improve bioavailability. Dexlansoprazole is the proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Dexlansoprazole blocks the final step in acid production, thus reducing gastric acidity. Construction of calibration curve of Dexlansoprazole and to investigate the drug and polymer interaction studies by FTIR and DSC. To prepare the different controlled release formulations of Dexlansoprazole tablets with different polymers such as acrylic acid polymer such as Carbopol-974P, HPMC grades for prevalence HPMC-K4M, HPMC-K15M, HPMCK100M, Natural Polymers akin to Xanthan gum, Guar gum, Sodium Carboxy Methyl Cellulose, and Pectin by Direct Compression method. Evaluation of Dexlansoprazole pre compression parameters such as Bulk density, Tapped density, Hausner’s ratio, Carr’s index, Angle of repose. Evaluation of post-compression parameters of Dexlansoprazole controlled release tablets such as Weight variation, Hardness, Friability test, Thickness, Drug Content and In-vitro dissolution studies. Evaluation of in-vitro dissolution uniqueness of all the formulations of Dexlansoprazole by using USP dissolution apparatus type-II (paddle). To study the mechanism of drug dissolution by applying kinetic parameters. To perform the stability studies of optimized formulations of Dexlansoprazole as per ICH guidelines.

Quality Evaluation of Locally Manufactured Paracetamol Tablets in East Africa.

Background: Paracetamol, also known as acetaminophen, is categorized as an analgesic and antipyretic medication and is available as over the counter (OTC) medication. It is commonly used in conditions associated with pain and fever. There is a tendency for community to prefer using imported paracetamol tablets from Europe and United States than from Asia and Africa worrying of the quality of the products. Safety, effectiveness, and efficacy of a medicine can be guaranteed when its quality is reliable; however, there is limited data on the quality of locally manufactured paracetamol tablets, thus necessitating this study. Aim: This study is aimed at assessing the quality of paracetamol tablets 500 mg manufactured by local companies by evaluating their physical parameters, assay results, and dissolution profiles. The compliance of these tablets with the specifications outlined in the British Pharmacopoeia (BP) was analyzed. Additionally, a comparative dissolution test was conducted to assess dissolution profile for innovator product and generics. Method: Five different brands from East African countries with 76 tablets from each brand were compared with the innovator product regarding weight variation, hardness, friability, assay, and dissolution test based on the BP specifications. Results and discussion: All samples of paracetamol tablets 500 mg from the local manufacturers in this study met the specifications set by the BP for physical parameters, including weight variation, friability, hardness, and disintegration tests. The weight variation test, directly related to drug content variation, demonstrated compliance within the acceptable deviation of 5%. Similarly, the assay test, which determines the concentration of the active pharmaceutical ingredient (API), confirmed that all samples complied with the acceptable concentration range of 90%-110% for paracetamol. The dissolution test, assessing the percentage release of the API within a specified time, demonstrated that at 15 min, two samples (diodol and enamol) exhibited lower concentration releases than the required 80%, indicating potential delays in their bioavailability and onset of action. Conclusion: To conclude, all samples had good quality and they can be used for their therapeutic purposes.

COMPARATIVE IN VITRO BIOAVAILABILITY TESTING FOR DIFFERENT BRANDS OF FLUCONAZOLE UNCOATED TABLETS

Our current study aimed to evaluate and compare the five different brands of Fluconazole tablets that are commercially available in Chennai. The physicochemical equivalence of five brands of Fluconazole tablets was determined through the evaluation of various standard parameters such as weight variation, friability, hardness, disintegration, dissolution rate, and amount of drug present. All the brands were found to be bioequivalent and comply with the official tests for weight variation, friability, disintegration, and dissolution tests. The tested brands showed identical drug release profiles. All the five brands evaluated can be considered as biopharmaceutical and physiochemically equivalent. Therefore, it is safe for the patients to switch over from one brand to another

Statistical Optimization of Fast Dissolving Tablet Contains Isosorbide Dinitrate for the Treatment of Angina Pectoris

ABSTRACT: The ultimate objective about this experiment was to create a fast-dissolving tablet Isosorbide dinitrate that released its medication quickly. The physical properties of tablets, such as hardness, angle of repose, weight variation, and friability were assessed. In-vitro release was investigated, and a 22-factorial design was created. The results show that the in-vitro release shows that the F2 formulation has the highest release at 20 min. Tablet disintegration time ranges from 31 to 48 s. The hardness ranges from 6-7 kg/cm3. The friability test shows the range from 0.49-0.68%. The weight variation test shows that all the formulation passes the tests. ANOVA statistical analysis revealed that the generated formulations are statistically significant. It is concluded that FDT formulations have optimum and reproducible disintegration time and increased dissolve characteristics, resulting in higher patient compliance.

Investigation of the binding properties of purified Pentadesma butyracea gum: Anatural alternative to a synthetic polymer

Abstract: The focus of most pharmaceutical research in recent times has been the use of natural products like gums as pharmaceutical excipients because they are safer, economical and readily available. This study aimed to investigate the applicability of gum extracted from the exudates from the stem bark of Pentadesma butyracea as a binder in conventional release tablets using acacia gum as a reference polymer. The purified Pentadesma butyracea gum (PBG) was precipitated from the crude gum mucilage using 96% ethanol. Conventional-release paracetamol tablets were formulated using seven (7) different concentrations of the PBG mucilage (0.5 – 6 %w/w) as a binder via wet granulation (PB1 – PB7). The same approach was used for the reference conventional release paracetamol tablets (AC1- AC7). The drug-excipients and excipients-gum compatibility studies were evaluated using the FTIR. The formulated tablets were evaluated using both pharmacopoeia and non-pharmacopoeia tests. Appropriate mathematical models were used to determine the similarity (f2) and the difference (f1) factors of the dissolution profiles of the test and reference formulations. Granules for batches PB1, AC1, PB2, AC2 and AC3 had fair flow properties, whereas the rest had good flow properties. The FTIR studies showed no interactions between the drug and excipients. All formulations passed the pharmacopoeia and non- pharmacopoeia tests except for formulations PB1, PB2, PB3 and AC1 which failed the friability test, PB1 and AC1 which failed the hardness test, and AC7 which also failed the disintegration test. An increase in gum concentration led to a corresponding increase in the mechanical properties of the tablets. A comparative study showed no significant difference in the hardness and tensile strength of the test and reference tablets. All formulations except PB6 were similar to their reference formulations since f1 &gt; 50 and f2 &lt; 15. In conclusion, the PBG exhibited a good binding property comparable to acacia gum.

The Effect Of Increasing Concentrations Of Sodium Saccharin As Sweetener On Physical Properties Of Salbutamol Dispersible Tablet With Mannitol As Filler

Salbutamol one of asthma medicine which can be made in to dispersible tablet with the addition of sodium saccharin as sweetener. This study aimed to determine effect of increasing concentration of sodium saccharin as sweetener on physical properties and patient acceptabelity of the tablet. The tablet was made into 5 formulas with the 0% of sodium saccharin concentration as Formula 1, 0.2% as Formula 2, 0.4% as Formula 3, 0.6% as Formula 4, and 0.8% as Formula 5. The tablet made by direct compression method. The evaluation of granule including flow time test, angle of repose, and compressibility test. The tablet evaluation including organoleptic, weight uniformity, size uniformity, friability, hardness, wetting time, disintegration time, content uniformity, and hedonic test. The results of the physial properties were the hardness F1 until F5 subsequently 1.70, 1.54, 2.48, 2.67, and 2.73 Kp; the disintegration time F1 until F5 subsquently 55.67, 56.67, 56.67, 57.00, and 58.00 seconds; the friability test 1.09, 1.98, 0.77, 0.65, and 0.63%. The results showed that there were significant differences among all the formulas. It could be concluded that increasing concentration of sodium saccharin as sweetener in salbutamol dispersible tablet increase physical properties and could be made as preferable and acceptable tablet.

Scaling up and evaluation of Dyphylline controlled release matrix tablets

The aim of the current study was to scale up controlled release matrix tablets of Dyphylline, used for the management of various respiratory conditions such as asthma, cardiac dyspnea, chronic bronchitis, and emphysema. The tablets were scaled up to 3500 tablets scale then the optimized formulations were further scaled up to 35000 tablets. Tablets were manufactured using direct compression, wet granulation, and hot melt methods. The prepared tablets were evaluated for Hardness, Friability, content uniformity, in-vitro drug release, and stability study. The results obtained showed that the ten prepared tablets showed accepted values for the hardness, friability, and content uniformity tests. The formulations showed controlled drug release profiles with high similarity to our target release profile (f values ranged from 63.9 to 84.9). The release profiles showed a better fit to zero order than diffusion model. The Exponent n of Korsmeyer-Peppas model ranged from 0.67 to 0.692 indicating non-Fickian diffusion. The stability study indicating good stability of the selected formulation. All these results concluded that formulation prepared by wet granulation can be manufactured on large scale perfectly.