Disintegration Time Of Tablets Research Articles

Impact of process parameters on Mg–St content and tablet surface wettability in the external lubrication method for a rotary tablet press

External lubrication is a new alternative used in compression processes of the pharmaceutical industry to minimize the negative effect of lubricant and to resolve sticking problems. This method can also prevent the deterioration of tablet properties; e.g., reduced tensile strength and a retarded rate of drug dissolution. The current study prepared tablets using the external lubrication method with varying potential critical process parameters and clarified the process of external lubrication via statistical analysis. In accordance with past results, tablets prepared using the external lubrication method had better tablet properties (higher hardness and more rapid disintegration) than those prepared using the internal lubrication method. Quantitative analyses of the magnesium stearate content and contact angle showed that the wettability of the tablet surface increased with the magnesium stearate content. Analysis of variance showed that all potential critical parameters are influential for the magnesium stearate content, but not for the disintegration of tablets. In addition, predictions of the magnesium stearate content and disintegration time of tablets made using a model equation correlated well with observed values. The external lubrication method can thus be applied by identifying the critical process parameters in the compression process during the development and manufacture of pharmaceutical products.

A Holistic Multi Evidence Approach to Study the Fragmentation Behaviour of Crystalline Mannitol.

Mannitol is an essential excipient employed in orally disintegrating tablets due to its high palatability. However its fundamental disadvantage is its fragmentation during direct compression, producing mechanically weak tablets. The primary aim of this study was to assess the fracture behaviour of crystalline mannitol in relation to the energy input during direct compression, utilising ball milling as the method of energy input, whilst assessing tablet characteristics of post-milled powders. Results indicated that crystalline mannitol fractured at the hydrophilic (011) plane, as observed through SEM, alongside a reduction in dispersive surface energy. Disintegration times of post-milled tablets were reduced due to the exposure of the hydrophilic plane, whilst more robust tablets were produced. This was shown through higher tablet hardness and increased plastic deformation profiles of the post-milled powders, as observed with a lower yield pressure through an out-of-die Heckel analysis. Evaluation of crystal state using x-ray diffraction/differential scanning calorimetry showed that mannitol predominantly retained the β-polymorph; however x-ray diffraction provided a novel method to calculate energy input into the powders during ball milling. It can be concluded that particle size reduction is a pragmatic strategy to overcome the current limitation of mannitol fragmentation and provide improvements in tablet properties.

The effect of superdisintegrants on the properties and dissolution profiles of liquisolid tablets containing rosuvastatin

Context: The preparation of liquisolid systems (LSS) represents a promising method for enhancing a dissolution rate and bioavailability of poorly soluble drugs. The release of the drug from LSS tablets is affected by many factors, including the disintegration time.Objective: The evaluation of differences among LSS containing varying amounts and types of commercially used superdisintegrants (Kollidon® CL-F, Vivasol® and Explotab®).Materials and methods: LSS were prepared by spraying rosuvastatin solution onto Neusilin® US2 and further processing into tablets. Varying amounts of superdisintegrants were used and the differences among LSS were evaluated. The multiple scatter plot method was used to visualize the relationships within the obtained data.Results and discussion: All disintegrants do not showed negative effect on the flow properties of powder blends. The type and concentration of superdisintegrant had an impact on the disintegration time and dissolution profiles of tablets. Tablets with Explotab® showed the longest disintegration time and the smallest amount of released drug. Fastest disintegration and dissolution rate were observed in tablets containing Kollidon® CL-F (≥2.5% w/w). Also tablets with Vivasol® (2.5–4.0% w/w) showed fast disintegration and complete drug release.Conclusion: Kollidon® CL-F and Vivasol® in concentration ≥2.5% are suitable superdisintegrants for LSS with enhanced release of drug.

Development of In Vitro–In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls

Although in vitro-in vivo correlations (IVIVCs) are commonly pursued for modified-release products, there are limited reports of successful IVIVCs for immediate-release (IR) formulations. This manuscript details the development of a Multiple Level C IVIVC for the amorphous solid dispersion formulation of suvorexant, a BCS class II compound, and its application to establishing dissolution specifications and in-process controls. Four different 40 mg batches were manufactured at different tablet hardnesses to produce distinct dissolution profiles. These batches were evaluated in a relative bioavailability clinical study in healthy volunteers. Although no differences were observed for the total exposure (AUC) of the different batches, a clear relationship between dissolution and Cmax was observed. A validated Multiple Level C IVIVC against Cmax was developed for the 10, 15, 20, 30, and 45 min dissolution time points and the tablet disintegration time. The relationship established between tablet tensile strength and dissolution was subsequently used to inform suitable tablet hardness ranges within acceptable Cmax limits. This is the first published report for a validated Multiple Level C IVIVC for an IR solid dispersion formulation demonstrating how this approach can facilitate Quality by Design in formulation development and help toward clinically relevant specifications and in-process controls.

Formulation and Evaluation of Mouth Dissolving Tablets of Piroxicam

Piroxicam, a non-steroidal anti-inflammatory agent, is widely used in rheumatoid arthritis, osteoarthritis, musculo-skeletal disorders, dysmenorrhoeal and post-operative pain. It has poor bioavailability due to its inherent properties. The objective of present study is to enhance water solubility of Piroxicam by solid dispersion technique and to develop novel method of preparing compressed tablets for Piroxicam with high porosity which dissolves rapidly in mouth, using camphor as sublimating agent and super disintegrants such as Crosscarmellose sodium and sodium starch glycollate. The tablets were evaluated for hardness, thickness, friability, weight variation, wetting time, disintegration time, drug content and in vitro drug release. Optimized formulation was evaluated for stability according to ICH guideline. All tablets had hardness in range of 2.8-3.1 kg/cm2 and friability of all formulations was less than 1.0%. Weight variation and drug content were within USP limits. A stability study for optimized F6 formulation 40 °C / 75 % RH for 30 days showed little change in drug content. Therefore, it is concluded that enhance solubility and increased levels of the super disintegrants Cross carmellose sodium and sodium starch glycollate increases the rate of Piroxicam release. Camphor decreases disintegration time of tablets and create high porosity which dissolve rapidly in mouth and could be industrially feasible.

Utilization of Cellulose fromLuffa cylindricaFiber as Binder in Acetaminophen Tablets

Cellulose is an important pharmaceutical excipient. This study aimed to produce cellulose from the fiber ofLuffa cylindricaas an effective binder in the formulation of acetaminophen tablets. This study was divided into three phases, namely, (I) preparation of cellulose fromLuffa cylindrica, (II) determination of the powder properties of the LC-cellulose, and (III) production and evaluation of acetaminophen of the tablets produced using LC-cellulose as binder. The percentage yield of LC-cellulose was 61%. The values of the powder properties of LC-cellulose produced show fair and passable flow properties and are within the specifications of a powdered pharmaceutical excipient. The mean tablet hardness and disintegration time of the LC-cellulose tablets have a significant difference in the mean tablet hardness and disintegration time of the tablets without binder; thus the cellulose produced improved the suitability of acetaminophen in the dry compression process. However, the tablet properties of the tablets produced using LC-cellulose as binder do not conform to the specifications of the US pharmacopeia; thus the study of additional methods and excipients is recommended.

Preparation of Microcrystalline Cellulose from Cotton and its Evaluation as Direct Compressible Excipient in the Formulation of Naproxen Tablets

Microcrystalline cellulose (MCC) was prepared by acid hydrolysis from the cellulose purified from the cotton. Chemical assay, determination of degree of polymerization (DP) and FT-IR confirm the identification of prepared microcrystalline cellulose. The FT-IR spectrum of synthesized MCC is very similar to that of Avicel® PH- 102, a commercial direct compression excipient, at consideration of both band position and intensity. The degree of polymerization (DP) of prepared MCC and Avicel PH102, determined from the value of intrinsic viscosity, were 210 and 240, respectively. The tableting properties of prepared MCC was excellent while formulating naproxen tablet. The hardness and friability of the tablets prepared from MCC was 5.33 ± 0.45 kg and 0.077%, respectively which were comparable to the tablets prepared from marketed Avicel PH102 having hardness and friability 7.35 ± 0.41 kg and 0.063%, respectively. The disintegration time of tablet prepared from MCC and Avicel PH102 was 8.25 ± 0.41 min and 4.50 ±0.28 min, respectively. Again, the tablets prepared from MCC and Avicel PH102 showed more than 90% and 98% dissolution, respectively as per the USP specified medium. All these data indicate that the hardness, friability, disintegration and dissolution properties of tablets prepared by using our MCC comply with the USP specifications. This makes the prepared MCC as a promising candidate for direct compressible excipient of tablet. DOI: http://dx.doi.org/10.3329/dujps.v13i2.21899 Dhaka Univ. J. Pharm. Sci. 13(2): 187-192, 2014 (December)

The Use of Synthetic Polymers (Superdisintegrants) in Technology Tablets Containing Ethanol Dry Extract from Asparagus officinalis

Dry extracts are now frequently used in medicine as an alternative to synthetic drugs. In the case of tablet technology with dry plant extracts, the proper selection of disintegrants (superdisintegrants) is particularly important. Objectives. The aim of this study was to evaluate the usefulness of the polymers constituting superdisintegrants (Vivasol®, Vivastar®, Polyplasdone XL) in uncoated tablet formulation of alcoholic extracted from Asparagus officinalis. Dry the ethanol extract of Asparagus officinalis, Vivasol®, Vivastar®, Vivapur®, Kollidon VA64, Polyplasdone XL, magnesium stearate. Direct compression. Paddle method was carried out to study pharmacopoeial parameters and pharmaceutical availability. The calculation of equivalency factors: similarity [f2] and the difference [f1]. Approximation results. Tablets brownish-green, with a smooth and uniform surface, without stains, chipping and damage. The determined average weight of the tablets compiled with the standards. The test friability and crushing strength revealed that the most mechanically strong tablets contained Vivasol, Vivastar, Polyplasdone XL. These tablets also have a longer disintegration and dissolution time compared with tablets containing only Vivasol. These differences are also confirmed by the calculated f2 and f1. The addition of a mixture of Polyplasdone XL and Vivastar to Vivasol significantly increases the mechanical strength of the tablets (crushing strength, resistance to crushing). The addition of a mixture of Polyplasdone XL and Vivastar to Vivasol paradoxically increases the disintegration time of tablets (11.1 min). Single superdisintegrant breaks up the tablet more effectively than a mixture of superdisintegrants.

Use of a continuous twin screw granulation and drying system during formulation development and process optimization

Since small scale is key for successful introduction of continuous techniques in the pharmaceutical industry to allow its use during formulation development and process optimization, it is essential to determine whether the product quality is similar when small quantities of materials are processed compared to the continuous processing of larger quantities. Therefore, the aim of this study was to investigate whether material processed in a single cell of the six-segmented fluid bed dryer of the ConsiGma™-25 system (a continuous twin screw granulation and drying system introduced by GEA Pharma Systems, Collette™, Wommelgem, Belgium) is predictive of granule and tablet quality during full-scale manufacturing when all drying cells are filled. Furthermore, the performance of the ConsiGma™-1 system (a mobile laboratory unit) was evaluated and compared to the ConsiGma™-25 system.A premix of two active ingredients, powdered cellulose, maize starch, pregelatinized starch and sodium starch glycolate was granulated with distilled water. After drying and milling (1000μm, 800rpm), granules were blended with magnesium stearate and compressed using a Modul™ P tablet press (tablet weight: 430mg, main compression force: 12kN). Single cell experiments using the ConsiGma™-25 system and ConsiGma™-1 system were performed in triplicate. Additionally, a 1h continuous run using the ConsiGma™-25 system was executed. Process outcomes (torque, barrel wall temperature, product temperature during drying) and granule (residual moisture content, particle size distribution, bulk and tapped density, hausner ratio, friability) as well as tablet (hardness, friability, disintegration time and dissolution) quality attributes were evaluated.By performing a 1h continuous run, it was detected that a stabilization period was needed for torque and barrel wall temperature due to initial layering of the screws and the screw chamber walls with material. Consequently, slightly deviating granule and tablet quality attributes were obtained during the start-up phase of the 1h run. For the single cell runs, granule and tablet properties were comparable with results obtained during the second part of the 1h run (after start-up). Although deviating granule quality (particle size distribution and Hausner ratio) was observed due to the divergent design of the ConsiGma™-1 unit and the ConsiGma™-25 system (horizontal set-up) used in this study, tablet quality produced from granules processed with the ConsiGma™-1 system was predictive for tablet quality obtained during continuous production using the ConsiGma™-25 system.

Development of fast dispersing tablets of nebivolol: experimental and computational approaches to study formulation characteristics

Formulation of FDT (fast dispersing tablets) of nebivolol was optimized and evaluated using simplex lattice design (SLD). The influence of type and concentration of three disintegrants viz.,Ac-Di-Sol, Primojel and Polyplasdone XL on hardness, friability and disintegration time of tablet was studied. Response surface plot and the polynomial equations were used to evaluate influence of polymer on the tablet properties. Results were statistically analyzed using ANOVA, and a p < 0.05 was considered statistically significant. Results reveal that fibrous integrity and optimal degree of substitution in Primojel and Ac-Di-Sol are mainly responsible for the hardness of the tablet. Use of Polyplasdone in higher percentage in tablet formulation may result in high friability. Increase in concentration of Ac-Di-Sol increases the disintegration time but increased concentration of Primojel in the tablet formulation decreases the disintegration time. This is also evident from model terms for disintegration time with a high 'F' value of 14.69 and 'p' value of 0.0031 (<0.05). The reason could be that Primojel has higher swelling properties and an optimum hydration capacity, which favors fast disintegration of a tablet. In conclusion, careful selection of disintegrant for FDT could improve their properties. Use of Simplex Lattice Design for formulation development could simplify the formulation process and reduce the production cost.

Optimisation of Ondansetron Orally Disintegrating Tablets Using Artificial Neural Networks

Purpose: To investigate the impact of critical quality attributes (CQAs) and critical process parameters (CPPs) on quality target product profile (QTPP) attributes of orally disintegrating tablet (ODT) containing ondansetron (OND) using two artificial neural network (ANN) programs.Methods: Different amounts of two different commercial superdisintegrants commonly used in ODT formulations (Ludiflash® and Parteck®) were examined as CQAs, while three different tablet-pressing forces were evaluated as CPPs for an orally disintegrating tablet (ODT) formulation. The impact of CQAs, and CPPs on the target product profile (tablet hardness, friability and disintegration time) were analysed using gene expression programming (GEP) and neuro-fuzzy logic (NFL) models.Results: NFL model defined the relations between CQAs, CPPs and QTPP, while GEP model favoured the use of an ODT formulation with suitable QTPP features which contained 4 mg ondansetron, 21.30 mg Parteck®, and 119 mg Avicel, fabricated with a compression force of 515 psi. In this regard, the tablet formulation demonstrated the required specifications.Conclusion: ANN programs are a useful tool for research and development (R&D) studies in the pharmaceutical industry and the use of ANNs can be beneficial in terms of raw materials, time and cost, as demonstrated for ondansetron ODT tablets.Keywords: Ondansetron, Critical quality attributes, Critical process parameters, Quality target product profile, Gene expression programming, Neuro-fuzzy logic, Artificial neural network

Predicting the gastrointestinal behaviour of modified-release products: Utility of a novel dynamic dissolution test apparatus involving the use of bicarbonate buffers

The establishment of physiologically relevant in vitro–in vivo correlations (IV–IVCs) is key for any biorelevant dissolution test. Historically, bicarbonate buffers have produced better correlations than compendial phosphate buffered media, though such tests are usually performed at a constant pH experiment, overlooking the notion that the pH of the luminal fluids is variable and fluctuating. In this work, we have devised a dynamic dissolution test method employing a physiological bicarbonate buffer under pH conditions of the proximal gut in order to assess the dissolution behaviour of various enteric polymer-coated (gastro-resistant) prednisolone tablets. The pH of the media is modulated and controlled by an Auto pH System™ which exploits the physiological equilibria between [H2CO3] and [HCO3−], to match it to the aboral change in pH with transit of the dosage form through the proximal small intestine (from pH 5.6 up to 6.8). The lag time values for an accelerated release and standard EUDRAGIT® L30D-55 coated formulation (25min and 60min, respectively) were close to the previously reported initial tablet disintegration time data obtained in-vivo by γ-scintigraphy (28min and 66min, respectively). Dissolution of alternative delayed release coated products was also better discriminated in the dynamic buffer system. These data confirm the dynamic dissolution system provides a robust and reliable platform to predict the in vivo fate of oral products in a laboratory setting.

Real‐Time Monitoring of Changes of Adsorbed and Crystalline Water Contents in Tablet Formulation Powder Containing Theophylline Anhydrate at Various Temperatures During Agitated Granulation by Near‐Infrared Spectroscopy

Real-time monitoring of adsorbed water content (FW) and hydrate formation of theophylline anhydrate (THA) in tablet formulation during agitated granulation was investigated by near-infrared (NIR) spectroscopy. As the wet-granulation process of THA tablet formulation involves change in pseudo-polymorphs between THA and theophylline monohydrate (THM), the pharmaceutical properties of THA tablet depend on the degree of hydration during granulation. After mixing of the powder materials (4 g) containing THA, and excipients and the addition of 600 μL of binding water, the powder was kneaded at 27°C, 40°C, and 50°C and then dried. The mixing, granulating, and drying processes were monitored using NIR. The calibration models to predict THM and total water contents during granulation in THA tablet formulation were obtained by partial least-squares regression. The FW in the formulation was determined by subtracting THM from the water content. The results of the THA formulation powder bed during granulation by NIR monitoring indicated that the transformation pathway of the THA powder was THA ⇒ THM ⇒ THA at 27°C and 40°C, but that at 50°C was THA ⇒ THA ⇒ THA. The pharmaceutical properties, such as tablet porosity, hardness, tablet disintegration time, and dissolution rate of the final THA tablet products, were affected by the degree of crystalline transformation during granulation.

Comparative Quality Evaluation of Different Brands of Frusemide Tablets Available in Bangladeshi Market

Frusemide is a widely produced and marketed drug by many Pharmaceutical companies in Bangladesh. The performance evaluation (Namely, some physical parameters, potency, disintegration and dissolution profile), of Frusemide tablets from six different pharmaceutical companies was carried out in order to find out whether they really complied the required standards. As a part of evaluation of physical parameters, the size and shape, specially, thickness of representative samples of each pharmaceutical companies were evaluated and they were found to be uniform. The tablets from all the companies successfully passed the friability test as the % of friability of all of them were found to be way below one. Out of the tablets of six evaluated pharmaceutical companies, the potency of Frusemide tablets from five companies was found to be satisfactory and one was poor. The disintegration time of tablets from all the companies were found to be satisfactory. The minimum disintegration time was found to be 2.50 minute and the maximum disintegration was found to be 5 minutes. The dissolution profile of the representative sample was determined. The profiles for all the companies were satisfactory. The best profile was showed 90.42% at 45 minutes and 92.50% at 50 minutes.

Performance of tablet disintegrants: impact of storage conditions and relative tablet density

Tablet disintegration can be influenced by several parameters, such as storage conditions, type and amount of disintegrant, and relative tablet density. Even though these parameters have been mentioned in the literature, the understanding of the disintegration process is limited. In this study, water uptake and force development of disintegrating tablets are analyzed, as they reveal underlying processes and interactions. Measurements were performed on dibasic calcium phosphate tablets containing seven different disintegrants stored at different relative humidities (5–97%), and on tablets containing disintegrants with different mechanisms of action (swelling and shape recovery), compressed to different relative densities. Disintegration times of tablets containing sodium starch glycolate are affected most by storage conditions, which is displayed in decreased water uptake and force development kinetics. Disintegration times of tablets with a swelling disintegrant are only marginally affected by relative tablet density, whereas the shape recovery disintegrant requires high relative densities for quick disintegration. The influence of relative tablet density on the kinetics of water uptake and force development greatly depends on the mechanism of action. Acquired data allows a detailed analysis of the influence of storage conditions and mechanisms of action on disintegration behavior.

Investigation of α-Cellulose Content of Sugarcane Scrappings and Bagasse as Tablet Disintegrant

The aim of this study is to investigate the physicochemical and disintegrant properties of α – cellulose obtained from sugarcane scrapings and bagasse. The mechanical and release properties of paracetamol tablets containing the extracted celluloses and two standard disintegrants- corn starch B.P and microcrystalline cellulose – were determined using crushing strength, friability, disintegration time, the time taken for 50% (T50) and 90% (T90) drug dissolution as assessment parameter. α – cellulose obtained from sugarcane scrapings and bagasse possess better flow properties than cornstarch and microcrystalline cellulose and are capable of absorbing up to five times their own weight in water and swell considerably. α – cellulose obtained from sugarcane scrapings and bagasse have high moisture sorption capacity and they formed relatively softer tablets which became increasingly harder as their concentration increased. All the tablets formulated with cellulose derived from sugarcane scrapings and bagasse passed the official disintegration test for uncoated tablets. Cellulose obtained from sugarcane bagasse had superior disintegrant property to cornstarch and microcrystalline cellulose while cellulose obtained from sugarcane scrapings showed comparable disintegrant property to microcrystalline cellulose. Tablets containing 2.5% w/w cellulose derived from sugarcane scrapings and 5.0% w/w cellulose derived from sugarcane bagasse gave more optimum result as tablet disintegrant. Formulations containing cellulose derived from sugarcane scrapings and bagasse show faster drug release (lower T50 and T90) than tablets containing corn starch and microcrystalline cellulose. There was a linear correlation between T90 and disintegration time (r = 0.976, p< 0.05) for tablets formulated with cellulose derived from sugarcane scrapings. Results show that α – cellulose obtained from sugarcane bagasse and scrapings are potentially useful as disintegrants in tablet formulations.

Pre-Clinical Evolutionary Study of Alpha-Pinene in L-Arginine Induced Acute Pancreatitis in Rat.

Abstract: The purpose of this study was to design matrix tablets of hydralazine hydrochloride to overcome its side effects and to increase its bioavailability. Hydroxypropyl methylcellulose, carbomer, glyceryl dibehenate and cetyl alcohol were used in matrix tablets at various concentrations for sustained drug delivery. Compression and flow properties of powder mixtures were tested before tablets were compressed by direct compression method. Weight variation, diameter and thickness, hardness, tensile strength, friability % and disintegration time of tablets were tested for their physical characterization. Drug:excipient compatibility in tablets was investigated by Fourier Transform Infrared Spectroscopy and Differential Scanning Calorimetry. Determination method of drug in dissolution mediums was validated through following performance criteria: linearity, intra- and inter-day precision, accuracy, specifity and recovery. All formulations met compendial requirements and any chemical interaction between drug and tablet excipients was not detected. It was observed that waxy tablets released drug faster than polymer based tablets. The slowest drug release rate was obtained with carbomer matrix tablets followed by hydroxypropyl methylcellulose, glyceryl dibehenate and cetyl alcohol. Drug release met Higuchi kinetic model in general. While the mechanism of drug release from polymer based tablets was non-Fickian, waxy tablets generally displayed diffusionally controlled drug release. Keywords: Hydralazine HCl, Controlled release, Matrix tablets, Polymers, Lipids

Comparative Quality Evaluation of Different Brands of Frusemide Tablets Available in Bangladeshi Market

Frusemide is a widely produced and marketed drug by many Pharmaceutical companies in Bangladesh. The performance evaluation (Namely, some physical parameters, potency, disintegration and dissolution profile), of Frusemide tablets from six different pharmaceutical companies was carried out in order to find out whether they really complied the required standards. As a part of evaluation of physical parameters, the size and shape, specially, thickness of representative samples of each pharmaceutical companies were evaluated and they were found to be uniform. The tablets from all the companies successfully passed the friability test as the % of friability of all of them were found to be way below one. Out of the tablets of six evaluated pharmaceutical companies, the potency of Frusemide tablets from five companies was found to be satisfactory and one was poor. The disintegration time of tablets from all the companies were found to be satisfactory. The minimum disintegration time was found to be 2.50 minute and the maximum disintegration was found to be 5 minutes. The dissolution profile of the representative sample was determined. The profiles for all the companies were satisfactory. The best profile was showed 90.42% at 45 minutes and 92.50% at 50 minutes.

Release kinetics of papaverine hydrochloride from tablets with different excipients.

The influence of excipients on the disintegration times of tablets and the release of papaverine hydrochloride (PAP) from tablets were studied. Ten different formulations of tablets with PAP were prepared by direct powder compression. Different binders, disintegrants, fillers, and lubricants were used as excipients. The release of PAP was carried out in the paddle apparatus using 0.1 N HCl as a dissolution medium. The results of the disintegration times of tablets showed that six formulations can be classified as fast dissolving tablets (FDT). FDT formulations contained Avicel PH 101, Avicel PH 102, mannitol, (3-lactose, PVP K 10, gelatinized starch (CPharmGel), Prosolv Easy Tab, Prosolv SMCC 90, magnesium stearate, and the addition of disintegrants such as AcDiSol and Kollidon CL. Drug release kinetics were estimated by the zero- and first-order, Higuchi release rate, and Korsmeyer-Peppas models. Two formulations of the tablets containing PVP (K10) (10%), CPharmGel (10% and 25%), and Prosolv Easy Tab (44% and 60%) without the addition of a disintegrant were well-fitted to the kinetics models such as the Higuchi and zero-order, which are suitable for controlled- or sustained-release.

Evaluation of Goat Fat as Potential Co-Lubricant in Pharmaceutical Tablet Dosage Form

In this study, goat fat co-processed with a combination of magnesium stearate and talc (GMT) was evaluated as a lubricant and compared with magnesium stearate plus talc (MT) and without lubricant using flow of granules, mechanical properties of tablets of crushing strength, the disintegrant properties of tablet disintegration time (DT) and crushing strength friability/disintegration time ratio (CSFR/DT) as assessment parameters. Granules were lubricated with different concentrations of 0.5% w/w, 1.5% w/w, 2.0% w/w and 2.5% w/w of the co-processed lubricant of goat fat, magnesium stearate and talc (GMT) and combination of magnesium stearate and talc (MT) and without lubricant in a paracetamol tablet formulation. The flow of the granules quantified as Hausner ratio, Carr’s index, and angle of repose showed that granules lubricated with the co-processed lubricant of goat fat (GMT) improved the flow properties of paracetamol granules compared to granules lubricated with magnesium stearate and talc alone. The tablet properties of paracetamol prepared from granules lubricated with GMT were comparable with tablets prepared from granules lubricated with MT and without lubricant. The tablets produced by GMT possessed acceptable crushing strength, friability and disintegration time and thus CSFR/DT. The study shows that the lubricant type and concentration influenced the crushing strength and disintegration time of the tablets and the co-processed lubricant could also be useful in situations where a low crushing strength friability/ disintegration (CSFR/DT) value is required, such as sustained release tablet.