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Based on the dual needs of analgesia and anti-inflammation in trauma treatment, this study uses acetaminophen and moxifloxacin hydrochloride as active pharmaceutical ingredients and develops a composite bilayer tablet with a dual-phase drug release system by using binder jet 3D printing technology. Due to the complexity of the 3D printing process, there is an interaction between the various parameters. Through the optimization of the process, the relationship between the key process parameters can be determined more intuitively. In this study, the process of extended-release tablets was optimized to maintain the mechanical properties of the tablets while realizing the regulation of release. The full-factor experimental design of three central points 23 was used to analyze the factors that significantly affect the quality attributes of extended-release tablets and the interaction between factors. The optimal extended-release process parameters were obtained by the response optimizer: the inkjet quantity of the printing ink was 10 (about 13.8 pL), the powder thickness was 180 μm, and the running speed was 360 mm·s-1. The in vitro of release of 3D printed composite bilayer tablets showed that the in vitro of release of 3D printed tablets and commercially available tablets conformed to the Ritger-Peppas release model. The results of porosity showed that the immediate-release layer of the preparation has many pores and large pore size, and the dissolution of the immediate release layer within 15 min was greater than 85%. The internal pore size of the extended release layer is large, but it can still release slowly for up to 8 h, the mechanism may be related to the extended release of HPMC gelation. On the basis of verifying the rationality of the design goal of 3D printed composite bilayer tablets, this study also provides a theoretical basis for the preparation of 3D printing complex preparations.
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Abstract The present study aimed to compare the crude, modified and hydrolyzed gums of Dalbergia sissoo and Acacia modesta as a biodegradable binder for drug delivery system using acetaminophen as a model drug. The physiochemical properties such as pH, fluorescence analysis and swelling index were determined. The gums were hydrolyzed and modified. Acetaminophen tablets were prepared using wet granulation technique and the gum solutions were used as a binder. Hydroxypropyl methylcellulose was used as a synthetic binder. Different properties of granules and tablets were evaluated. Results showed that both gums were acidic in nature, while D. sissoo and A. modesta showed light brown and creamy color in fluorescence analysis. The swelling ratio was the highest in water followed by 0.1N HCl and least in phosphate buffer. The prepared tablets showed faster and slower dissolution profiles in the same dissolution system. The crude gums have the highest dissolution rate, and this rate was decreased in the case of modified and hydrolyzed gums samples. The crude gums showing slower release can be useful in sustained-release tablets, while the modified gums having faster release rate are helpful in conventional tablet formulation. Taken together, the selected gums could be a good model for evaluation as a binder or hydrophilic polymer in tablet formulation.
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The purpose of the present study was to investigate the relationship of the classification of traditional Chinese medicine(TCM) materials with the suitable binder concentration and dosage in the preparation of personalized water-paste pills and establish a model for predicting the binder concentration and dosage. Five representative TCM materials were selected, followed by mixture uniform design. The water-paste pills were prepared by extrusion and spheronization with hypromellose E5(HPMC E5) as the binder. The quality of intermediates and final products was evaluated, and the resulting data were subjected to multivariate statistical analysis. The prediction models for binder concentration and dosage were established as follows: binder concentration: Y_1=0.378 6 + 0.570 1X_A + 2.271 2X_B-0.894 5X_C-0.458 2X_D-1.145 4X_E(when Y_1 < 0, 10% HPMC E5 was required; when Y_1 > 0, 20% HPMC E5 was required), with the accuracy reaching up to 100%; binder dosage: Y_2=32.38 + 0.25X_A + 1.85X_B-0.013X_B~2-0.002 5X_C~2(R~2=0.932 6, P < 0.001). The results showed that the binder concentration and dosage were correlated positively with the proportion of fiber material but negatively with the proportions of sugar material and brittle material. Then the validation experiments were conducted with the prediction models and all the prescriptions could be successfully prepared at one time. These demonstrated that following the classification of TCM materials and the calculation of their proportions in the prescription, the established mathematical model could be adopted for predicting the binder concentration and dosage required in the preparation of personalized water-paste pills, which contributed to reducing the pre-formulation research and guiding the actual production of personalized water-paste pills.
Subject(s)
Drugs, Chinese Herbal , Excipients , Hypromellose Derivatives , Medicine, Chinese Traditional , WaterABSTRACT
The development of printing ink is a challenge for binder jetting 3D printed preparations, which directly determines the quality of the printed product. This study adopted a 23 full-factor Design of Experiment (DoE) with three central points to optimize the printing ink composition of levetiracetam 3D printed dispersible tablet based on the concept of Quality by Design. Firstly, using polyvinyl pyrrolidone K30, glycerin and polysorbate 20 as independent variables based on 40% (v/v) isopropanol aqueous solution, and weight variation, hardness, friability and dispersion uniformity of the printed tablets were used as dependent variables. Then obtained the design space of the printing ink prescription by DoE model analysis, and the response optimizer was used to obtain the optimal printing ink prescription: isopropanol aqueous solution containing 0.1% (w/w) polyvinyl pyrrolidone K30 and 4.0% (w/w) glycerin. The jetting mechanism and wettability of the printing ink were analyzed, and different strengths of personalized 3D printed tablets were prepared and characterized, which verified the rationality of the printing ink formulation. This study provided a reference for the development of printing ink for binder jetting 3D printed preparations.
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OBJECTIVE：To study influential factors for medication compliance of phosphate binder in patients with maintenance hemodialysis and the effects of pharmacist intervention ，and to improve medication compliance and the effects of disease control. METHODS ：The patients with maintenance hemodialysis who were treated in the blood purification center of our hospital from Jun. to Dec. ，2019 were selected for questionnaire survey. The questionnaires involved general information ， medication compliance of phosphate binder ，disease and medicine related knowledge ，social support ，self-efficacy. The t-test，χ2 test and multivariate Logistic regression analysis were used to analyze influential factors for medication compliance. The patients were randomly divided into pharmaceutical intervention group and non-intervention group. Intervention group were provided with pharmaceutical care for 3 months according to risk factors. Blood phosphorus level and medication compliance was compared between 2 groups. RESULTS ：Totally 298 patients completed the survey （effective recovery rate of 96.1％）. Among them ，163 patients（54.7％）had good adherence to phosphate binder ，while 135 patients（45.3％）had poor compliance. Results of single factor analysis showed that medication compliance of phosphate binder was closely associated with age ，dialysis duration ， parathyroid hormone levels ，total daily dose ，daily dose of phosphate binder ，disease and medicine related knowledge scores ， social support ，self-efficacy（P＜0.05）. Results of multivariate Logistic regression analysis showed that total daily dose ，daily dose of phosphate binder ，disease and medicine related knowledge scores ，social support and self-efficacy were the influential factors for medication compliance （P＜0.05 or P＜0.01）. Medication compliance ，disease control status ，disease and medicine related knowledge score ， social support and self-efficacy in pharmaceutical intervention group were significant improved ， blood phosphorus level was significant lower ，compared with non-intervention group （P＜0.05）. CONCLUSIONS ：Independent risk factors influencing medication compliance of phosphate binder include total daily dose ，daily dose of phosphate binder ，disease and medicine related knowledge scores ，social support and self-efficacy. The patients with maintenance hemodialysis have poor compliance to phosphate binder. Pharmacists should take individualized and targeted intervention measures for the above risk factors，which can effectively improve the medication compliance and disease prognosis of patients.
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Background: Kinesiophobia has been reported as one of the most common factors that hinder the exercise based cardiac rehabilitation. According to the evidences in the literature and clinical observations, chest binder is prescribed post median sternotomy to reduce the postoperative complaints and complications. Till date no sufficient evidence has been reported regarding effectiveness of chest binder on kinesiophobia in CABG patients post median sternotomy. Purpose: To assess the effect of chest binder on the level of kinesiophobia; in CABG patients over a period of one month. Participants: Total 70 (50 – males; 20 – females) post CABG via median sternotomy, hemodynamically stable patients, aged between 40 – 70 years, with Tampa Scale for kinesiophobia – short version (TSK – SV) Heart scores > 37 were included. Methods: On the 4th post operative day, patients were assessed for level of kinesiophobia using TSK – SV Heart. The patients were divided in to two groups depending on the prescription of chest binder by their surgeons as Group A (with binder), Group B (without binder). One month post CABG, the patients in both the groups were asked to fill the TSK – SV Heart, via telephonic conversation. Analysis: Comparison of TSK – SV Heart score at baseline and after one month within Group A and Group B was done using Wilcoxon signed rank test with continuity correction. Comparison of difference of TSK – SV Heart score at baseline and after one month between Group A and Group B was done using Mann – Whitney test. The p value < 0.05 was considered to be statistically significant. Results: The mean of TSK –SV Heart score on 4th day post CABG in group A and group B was 43.42 (±7.717) and 43.45 (±4.64) respectively. The mean of TSK –SV Heart score on one month post CABG in group A and group B was 35.82 (±8.372) and 39.51 (± 6.03) respectively. A significant reduction in kinesiophobia was observed in group A and group B, p-value 0.00001188 and 0.00007886 respectively. The 95% Confidence Interval (CI) median estimate of group A and group B was 7.9 (5.0 – 10.5) and 4.5 (3.0 – 6.0) respectively. The mean of difference of TSK – SV Heart score in group A and group B was 7.6 (±8.24) and 3.94 (±4.82) respectively. The reduction in kinesiophobia in group A was significantly more than in group B, p-value = 0.00792. The 95% Confidence Interval (CI) median estimate of the mean of difference of TSK – SV Heart score in group A and group B was 3.7 (2.48 – 4.92) Conclusion: There was significant reduction in kinesiophobia irrespective of the use of chest binder post CABG via median sternotomy over a period of one month. There was marked reduction in kinesiophobia in patients who were using chest binder. Implications: Use of chest binder is recommended in patients who have kinesiophobia to encourage their participation in exercise based cardiac rehabilitation.
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Regulatory binder is one of the essential documents that isrequired to be maintained by all clinical sites throughout the conduct of clinical trials and post completion of clinical trials. Managing regulatory binders for multiple studies has been challenging due to large volume of documents that needs to be maintained in a paper form especially when the site has 150-200 open studies. To utilize electronic regulatory binders to replace paper based regulatory binders for improve efficiency while maintaining regulatory compliance. Use of document management system effectively allows sites to store regulatory binders electronically.Electronic regulatory binders provide a new way of managing tons of documents in a simplified fashion that helps in redefining the process, tracking documents, reducing physical storage requirements, retention, preparation for monitoring visits, and in prompt audits.
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BACKGROUND: Chronic kidney disease (CKD)-mineral and bone disorder (MBD) and fracture risk are both closely related to declining renal function. Controlling hyperphosphatemia with phosphate binders is a basic principle of CKD-MBD treatment. The aim of this study was to identify differences in fracture risk between pre-dialysis CKD patients and end-stage renal disease (ESRD) on dialysis, and to evaluate the effects of phosphate binders on fracture risk in ESRD patients. METHODS: Data from a total of 89,533 CKD patients comprising CKD diagnosis, dialysis, fracture history, and phosphate binder prescription history from 2012 to 2016 were retrieved from the Health Insurance Review and Assessment Service Database. Multivariate Cox regression analyses were performed to identify whether dialysis or phosphate binders were associated with an increased fracture risk. RESULTS: Overall, the rate of fractures in pre-dialysis CKD patients was 74 per 1,000 patient-years, while that in dialysis patients was 84 per 1,000 patient-years. The risk of fracture in ESRD patients was higher than pre-dialysis CKD patients (hazard ratio, 1.16; 95% confidence interval, 1.12–1.21; P < 0.001) after adjusting for confounding variables. In addition, the fracture risk in patients who were not taking phosphate binders was 20.0% higher compared to ESRD patients taking phosphate binders. CONCLUSION: Fractures were more prevalent in ESRD patients on dialysis than pre-dialysis CKD patients. Use of phosphate binders was associated with a lower fracture risk in ESRD patients.
Subject(s)
Humans , Cohort Studies , Diagnosis , Dialysis , Hyperphosphatemia , Insurance, Health , Kidney Failure, Chronic , Prescriptions , Renal Insufficiency, ChronicABSTRACT
Binder syndrome, also called the congenital flat nose syndrome, is a rare congenital malformation with a flat facial profile, intermaxillary hypoplasia and malocclusion. Rhinoplasty plays an important part in the multidisciplinary surgical protocol for this syndrome, for which weak nasal framework and soft tissue underdevelopment have been considered a great challenge. We present a case of Binder syndrome of a 27-year-old male. The nose was reconstructed with a caudal septum replacement graft and bilateral extended spreader grafts using costal cartilage.
Subject(s)
Adult , Humans , Male , Costal Cartilage , Malocclusion , Nose , Rhinoplasty , TransplantsABSTRACT
The effect of blood magnesium disorder on chronic kidney disease (CKD) has been gradually confirmed in recent years. At present, magnesium homeostasis depends on dietary intake, gastrointestinal absorption and kidney metabolism. In recent years, it has been proposed that the magnesium concentration of dialysate and the influence of drugs (especially proton pump inhibitors) on magnesium homeostasis cannot be ignored in the treatment of CKD patients. Although the mechanism of the effect of magnesium on CKD has not been fully elucidated, recent studies suggest that magnesium deficiency may aggravate hypertension and vascular calcification in CKD patients, affecting mineral metabolism, leading to increased mortality. The application of different magnesium-based binders, such as magnesium citrate, calcium acetate/magnesium carbonate, and magnesium oxide, can help to alleviate the effect of low magnesium levels on CKD, which needs further research.
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Objective: To investigate the technical points and effectiveness of autogenous costal cartilage transplantation in repair of Binder's syndrome. Methods: Between June 2012 and June 2017, 8 cases of Binder's syndrome were admitted. There were 3 males and 5 females, aged 16-31 years (mean, 22 years). All patients were conformed to the typical manifestations of Binder's syndrome. The autogenous costal cartilage was harvested and carved into the nasal dorsum graft, nasal column graft, and nasal basement graft. Before and after operation, standard pictures of the anterior view, lateral view, and base view were taken to measure facial related parameters of nasal dorsum length, nasal columella-lobule ratio, nasofrontal angle, nasal columella-upper lip angle, nasal tip projection rate, and nasion projection. Then the effectiveness of this surgical procedure for Binder's syndrome was evaluated. Results: All incisions healed by first intention without acute infections. All patients were followed up 6-36 months, with an average of 18 months. The foreign body sensation in upper lip and scar hyperplasia in thoracic incision occurred in 1 case, respectively. The nasal morphology improved significantly and the coordinated relationships of the nose with the upper lip and face were restored postoperatively. Postoperative parameter measurements were taken in 6 cases. The nasal dorsum length, nasal columella-lobule ratio, nasofrontal angle, nasal columella-upper lip angle, nasal tip projection rate, and nasion projection at preoperation were significantly improved when compared with the values at 6 months after operation ( P0.05). Conclusion: Autogenous costal cartilage transplantation in repair of Binder's syndrome can obviously improve patients' appearance of the external nose and middle face, and obtain the persistent effectiveness.
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Objective@#To explore the influence of different cement spaces on the marginal adaptation of CAD/CAM zirconia inlay.@*Methods@#30 teeth extracted for orthodontic purpose were selected and divided into 3 groups (Group A 10 μm, Group B 30 μm, Group C 50 μm). The marginal spaces of inlays were recorded by the light-body Silicone impression material, and measured by microscope. The data were analyzed by SPSS 13.0.@*Results @# All the inlays fitted very well and all the marginal spaces were less than 120 μm. The shoulder of Group A was statistically lower than Group B and Group C (P < 0.05). The axial surface of Group B was statistically lower than Group C (P < 0.05).@*Conclusions @#CEREC zirconia inlay is satisfactory when the cement space is between 10-50 μm.
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OBJECTIVE:To investigate the effects of lanthanum carbonate on calcium and phosphate metabolism in maintenance hemodialysis(MHD)patients with high calcium and high phosphorus. METHODS:A total of 40 MHD patients with high calcium and high phosphorus in our hospital during May 2014-May 2015 were divided into control group(22 cases)and observation group (18 cases)according to therapy plan. Both groups received diet guidance and MHD treatment. Control group was given Hydrotalcite chewable tablets 1 g,during meal,tid. Observation group was additionally given Lanthanum carbonate chewable tablets 500 mg(for patients with blood phosphorus ≥2.26 mmol/L)or 250 mg(for patients with blood phosphorus <2.26 mmol/L),during meal,tid (adjusting after 4 weeks).Both groups received treatment for 3 months.The calcium and phosphorus metabolism indexes[blood calci-um,blood phosphorus,calcium and phosphorus product,immunoreactive parathyroid hormone(iPTH)and alkaline phosphatase] and phosphorus reducing efficacies were observed in 2 groups before and after treatment,and the occurrence of ADR was recorded. RE-SULTS:Before treatment,there was no statistical significance in calcium and phosphorus metabolism indexes between 2 groups(P>0.05).After treatment,there was no statistical significance in calcium and phosphorus metabolism indexes of control group,iPTH or alkaline phosphatase of observation group compared to before treatment(P>0.05);blood calcium,blood phosphorus,calcium and phosphorus product of observation group were significantly lower than before treatment and also lower than control group at corre-sponding time,with statistical significance(P<0.05).Total response rate of phosphorus reducing in observation group(88.89%)was significantly higher than control group(40.91%),with statistical significance(P<0.05). There was no statistical significance in the incidence of ADR between observation group(11.11%)and control group(4.55%)(P>0.05). CONCLUSIONS:The lanthanum carbonate can effectively decrease blood calcium and blood phosphorus levels in MHD patients with good safety.
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OBJECTIVE:To investigate the effects of lanthanum carbonate on calcium and phosphate metabolism in maintenance hemodialysis(MHD)patients with high calcium and high phosphorus. METHODS:A total of 40 MHD patients with high calcium and high phosphorus in our hospital during May 2014-May 2015 were divided into control group(22 cases)and observation group (18 cases)according to therapy plan. Both groups received diet guidance and MHD treatment. Control group was given Hydrotalcite chewable tablets 1 g,during meal,tid. Observation group was additionally given Lanthanum carbonate chewable tablets 500 mg(for patients with blood phosphorus ≥2.26 mmol/L)or 250 mg(for patients with blood phosphorus <2.26 mmol/L),during meal,tid (adjusting after 4 weeks).Both groups received treatment for 3 months.The calcium and phosphorus metabolism indexes[blood calci-um,blood phosphorus,calcium and phosphorus product,immunoreactive parathyroid hormone(iPTH)and alkaline phosphatase] and phosphorus reducing efficacies were observed in 2 groups before and after treatment,and the occurrence of ADR was recorded. RE-SULTS:Before treatment,there was no statistical significance in calcium and phosphorus metabolism indexes between 2 groups(P>0.05).After treatment,there was no statistical significance in calcium and phosphorus metabolism indexes of control group,iPTH or alkaline phosphatase of observation group compared to before treatment(P>0.05);blood calcium,blood phosphorus,calcium and phosphorus product of observation group were significantly lower than before treatment and also lower than control group at corre-sponding time,with statistical significance(P<0.05).Total response rate of phosphorus reducing in observation group(88.89%)was significantly higher than control group(40.91%),with statistical significance(P<0.05). There was no statistical significance in the incidence of ADR between observation group(11.11%)and control group(4.55%)(P>0.05). CONCLUSIONS:The lanthanum carbonate can effectively decrease blood calcium and blood phosphorus levels in MHD patients with good safety.
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ABSTRACT The aim of this study was to evaluate binding potential of Mulva neglecta mucilage (MNM) with subsequent comparison to PVP K30. Eight batches of Diclofenac sodium tablets were prepared by wet granulation technique keeping different concentrations (4, 6, 8 & 10% w/w) of Mulva neglecta mucilage (extracted from leaves of Mulva neglecta) and PVP K30 as standard binder. The granules of formulated batches showed bulk density (g/mL) 0.49 ± 0.00 to 0.57 ± 0.00, tapped density (g/mL) 0.59 ± 0.01 to 0.70 ± 0.01, Carr's index 09.27 ± 0.95 to 19.65 ± 0.59, Hausner's ratio 1.12 ± 0.00 to 1.24 ± 0.01 and angle of repose 30.37 ± 2.90 °C to 36.86 ± 0.94 °C. Tablets were compressed to hardness 7.50 to 7.95 kg/cm2. The tablets showed 0.39 ± 0.02 to 0.39 ± 0.01% friability and 7:20 to 14:00 min disintegration time. Granules and post-compression evaluation revealed that parameters assessed were all found to be within the pharmacopoeial limits. The results (hardness, disintegration and dissolution) proved that Mulva neglecta mucilage has better binding capacity for preparation of uncoated tablet dosage form as compared to PVP K30. Among all the formulations, MN-1 to MN-4 showed slow release as compared to PV-1 to PV-4 and thereby Mulva neglecta mucilage exhibited satisfactory drug release phenomenon tablets of diclofenac sodium.
RESUMO O objetivo deste estudo foi avaliar o potencial de ligação de mucilagem de Mulva neglecta (MNM), com posterior comparação ao PVP K30. Oito lotes de comprimidos de diclofenaco de sódio foram preparados pela técnica de granulação úmida, mantendo diferentes concentrações (4, 6, 8 e 10% w/w) de mucilagem de Mulva neglecta (extraída de folhas de Mulva neglecta) e PVP K30 como ligante padrão. Os grânulos de lotes formulados mostraram densidade aparente (g/mL) 0.49 ± 0.00-0.57 ± 0.00, densidade compactada (g/mL) 0.59 ± 0.01-0.70 ± 0.01, índice de Carr 09.27 ± 0.95-19.65 ± 0.59, a relação de Hausner 1.12 ± 0.00-1.24 ± 0.01 e ângulo de repouso 30.37 ± 2.90 °C a 36.86 ± 0.94 °C. Os comprimidos foram prensados à dureza de 7.50-7.95 kg/cm2. Os comprimidos apresentaram 0.39 ± 0.02-0.39 ± 0.01% friabilidade e 7:20-14:00 min de tempo de desintegração. A avaliação de grânulos e pós-compressão revelou que todos os parâmetros estavam dentro dos limites da farmacopeia. Os resultados (dureza, desintegração e dissolução) provaram que a mucilagem de Mulva neglecta tem maior capacidade de ligação na preparação da forma de dosagem de comprimido não revestido em relação à PVP K30. Entre todas as formulações, MN-1 e MN-4 mostraram liberação lenta em comparação com PV-1 e PV-4 e, assim, a mucilagem de Mulva neglecta exibiu liberação do fármaco satisfatória para os comprimidos de diclofenaco de sódio.
Subject(s)
Malva , Plant Mucilage/classification , Tablets , Diclofenac/analogs & derivativesABSTRACT
Purpose of this work was to evaluate binding efficiency of latex powder of Jatropha curcas in tablet dosage form. Tablets of BCS class I and II drugs Propoanolol hydrochloride and Oxcarbazepine respectively were prepared by wet granulation method. Various concentrations of latex powder of Jatropha curcas were tried for optimization of binder concentration. Tablets prepared were evaluated for weight variation, content uniformity, hardness, disintegration time, friability and drug release. Also tablet with standard binder Poly Vinyl Pyrolidone was prepared and compared with optimized formulations of natural binder. Tablets were successfully prepared by wet granulation method with all evaluation parameters well within official limits for all concentrations of binder for both the drugs. It has been observed that as concentration of binder increases hardness and disintegration time increases with decrease in friability and drug release. As compared with tablet prepared by standard binder, Poly Vinyl Pyrolidone, our optimized formulations have shown comparable results. The study revealed that latex powder of Jatropha Curcus can be used as alternative binder than synthetic binders as it is cost effective and easily available.
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Aim: The aim of this study is to formulate a standard dose of aqueous extract of Moringa oleifera leaves into tablets and to determine a suitable binder for the formulation. Methodology: Aqueous extract of Moringa oleifera leaves was extracted and formulated using different binders which included Maize Starch, Gelatin and Micro-crystalline Cellulose (MCC) to find out which one produce better tablets of aqueous extract of Moringa oleifera leaves. Formulations were characterized using various parameters such as physicochemical properties (bulk density, tapped density, moisture content, Hausner’s ratio, Carr’s index, ash value), strength (friability and crushing strength) and release properties (disintegration and dissolution times tests). The result showed that tablets formulated with Gelatin as a binder has lowest friability and disintegration time compared to those formulated with either MCC or maize starch. The crushing strengths were all within the acceptable limit (3 – 6 KgF) except maize starch which was higher. Conclusion: Moringa oleifera tablets were successfully formulated and based on experiments conducted, Gelatin is preferable in the formulation of Moringa oleifera tablets.
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To evaluate binding potential of Prunus domestica gum in tablets formulations. Six tablet batches (F-1B to F-6B) were prepared by wet granulation method, containing Avicel pH 101 as diluent, sodium diclofenac as model drug using 10, 15 and 20 mg of Prunus domestica gum as binder and PVP K30 was used as standard binder. Magnesium stearate was used as lubricant. Flow properties of granules like bulk density, tapped density, Carr index, Hausner’s ratio, angle of repose as well as physical parameters of the compressed tablets including hardness, friability, thickness and disintegration time were determined and found to be satisfactory. The FTIR spectroscopic analysis showed that the formulation containing plant gum is compatible with the drug and other excipients used in tablets formulation. Hence the plant gum has role as a potential binder in tablets formulations. The dissolution profile showed that tablets formulations containing Prunus domestica gum 15 mg/200 mg of total weight of tablet as binder showed better results as compared to PVP K30.
Para avaliar a propriedade aglutinante da goma Prunus domestica em formulações de comprimidos, seis lotes (F-1B para F-6B) foram preparados pelo método de granulação úmida, contendo Avicel pH 101 como diluente e diclofenaco de sódio como fármaco modelo, usando 10, 15 e 20 mg de goma de Prunus domestica como agente aglutinante e PVP K30 como aglutinante padrão. O estearato de magnésio foi utilizado como lubrificante. Propriedades de fluxo dos grânulos, como a densidade, índice de Carr, razão de Hausner, ângulo de repouso, bem como parâmetros físicos dos comprimidos, incluindo o tempo de dureza, friabilidade, espessura e desintegração foram determinados e se mostraram satisfatórios. A análise espectroscópica no FTIR mostrou que a formulação contendo goma vegetal é compatível com o fármaco e outros excipientes utilizados na formulação dos comprimidos. Assim, a goma vegetal tem papel potencial como aglutinante em formulações de comprimidos. O perfil de dissolução das formulações que contêm 15 mg/200 mg do peso total do comprimido em goma de Prunus domestica como aglutinante mostrou melhores resultados comparativamente ao PVP K30.
Subject(s)
Plant Gums/pharmacokinetics , Prunus domestica/chemistry , Tablets/analysis , Diclofenac/pharmacokinetics , Spectroscopy, Fourier Transform Infrared/methods , Dissolution/analysisABSTRACT
Starches from four new sweet potato genotypes were evaluate for use as tablet diluents, binders and disintegrants; using a commercially available maize starch as reference. The pre-formulation studies established low pH (5.1 - 5.9) and moisture content (10.0 - 13.1%), but high bulk density (0.50 - 0.58), tapped density (0.75 - 0.82) and true density (1.15 - 1.18) for the sweet potato starches. Hardness and friability of tablets formulated with sweet potato starches as binder were significantly better (p = 0.001) than similar compacts containing maize starch. The sweet potato starches also caused significantly faster tablet disintegration and release of paracetamol (p = 0.005). The results established the sweet potato starches as stronger pharmaceutical diluents, binders and disintegrants, compared to the commercially available maize starch.
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Background: Unani medicines are being used since antiquity. However, in spite of their effi cacy, they have been widely criticized due to lack of standardization and poor quality presentation. For this reason, application of good manufacturing practices and development of standard operating procedures (SOPs) in the manufacture of herbal medicines became an essential tool to assure their quality. Objectives: Therefore, the objective of the study was to develop the SOP of Habbe Shifa (HS) regarding the particle size (PS), binder, temperature of drying, and duration of drying. Materials and Methods: In this study, 24 batches of HS were prepared according to the instructions given in formulary to develop SOP. Three particle sizes (i.e., 80, 100, and 120 No. Mesh sieve), were taken for preparation of pills. Water and Samaghe Arabi (Gum Acacia mucilage [GAM]) were used as binder for preparing the lubdi (mass) in different batches. Different temperature and duration of drying were used to dry the pills in hot air oven to get satisfactory results. All the batches were assessed three times for hardness, friability, and disintegration time and mean regarded as standard parameter value. Results and Conclusion: The batch with 150 m PS (100 mesh sieve), 5% w/w GAM used as a binder, dried at 90°C for 120 min showed hardness 3.50 ± 0.00 kg/cm, friability 0.02 ± 0.003%, and disintegration time 25.00 ± 0.57 min, which showed most appropriate result among all batches and considered as fi nal batch. Its SOP may be used for future reference which can help in setting up regulatory limit to assure the quality of Unani medicines.