Investigation of the disperse composition and strength of granules of instant drinks

В условиях высокой занятости населения возникает необходимость развития более сбалансированного питания. Одним из таких продуктов могут выступать инстантированные напитки на основе плодово-ягодного сырья. Подавляющее большинство таких продуктов на рынке представлено в виде многокомпонентного гранулятора с заданными показателями качества. При производстве таких продуктов используются грануляторы различного типа, однако для малых производств, которые могут быстро переориентироваться на выпуск новой продукции, более перспективными являются грануляторы периодического действия, например, роторные смесители-грануляторы. Однако при анализе получаемого дисперсного состава было выявлено, что продукт имеет нестабильный гранулометрический состав. В работе исследовались дисперсный состав и прочность гранулированного продукта, полученного в роторном смесителе-грануляторе. В результате литературно-патентного обзора была предложена модернизация известного гранулятора и определен дисперсный состав получаемых гранул. В результате проведенных исследований было выявлено, что гранулометрический состав готовой продукции стал более стабилен по сравнению с прототипом оборудования. При анализе прочности получаемых гранул не было выявлено существенного изменения, однако была выявлена зависимость прочности на раздавливание от частоты вращения рабочих органов, так при увеличении частоты вращения лопасти выше 2000 мин-1 наблюдался рост прочности гранул. Также при увеличении частоты вращения происходит рост мелкодисперсной фракции в готовой продукции. Обработка полученных результатов исследований позволила получить экспериментально статистическую модель зависимости среднемедианного размера получаемых гранул от режимных параметров и свойств связующего раствора. In conditions of high employment of the population, it becomes necessary to develop more balanced nutrition. One of the types of such foods can be instantized drinks based on fruit and berry raw materials. An overwhelming majority of these foods on the market are presented in the form of a multicomponent granules with specified quality indicators. When manufacturing such foods granulators of different types are used, however, for minor productions that can be quickly reorientated to the release of new foodstuffs, periodical activity granulators are more promising, for example, rotary mixers-granulators. However, when analyzing the resulting dispersed composition, it was revealed that the foodstuff has an unstable particle size distribution. The work investigated the dispersed composition and strength of the granular staff obtained in a rotary mixer-granulator. As a result of the literature and patent review, the modernization of the well-known granulator was proposed and the dispersed composition of the resulting granules was determined. As a result of the research carried out, it was revealed that the granulometric composition of the finished staff became stabler in comparison with the prototype of the equipment. When analyzing the strength of the granules obtained, no significant change was revealed, however, the dependence of the crushing strength of the working bodies’ rotational speed was revealed, so, with an increase in the blade’s rotational speed over 2000 RPM, an increase in the strength of the granules was observed. Also, with an increase in the rotational speed, an increase in the fine fraction in the product finished occurs. The processing of the research results obtained made it possible to obtain an experimental statistical model of the dependence of the average median size of the granules obtained on the operating parameters and the properties of the binder solution.

STUDY OF THE FUNCTIONALITY OF A NOVEL SOLUTION BINDER OBTAINED FROM OCIMUM BASILICUM SEEDS: A MECHANISTIC APPROACH

Objective: The aim of the present study was to investigate the functionality of the hydrogel isolated from the seeds of Ocimum basilicum (Gel) as a novel solution binder. Methods: Paracetamol is known to possess poor manufacturability. Therefore it was selected as a model drug to study the efficiency of Gel as a solution binder. Paracetamol tablets were prepared at gradually increasing compression pressure from the granules prepared by using Gel of various viscosities as a solution binder. Compactibility parameter was calculated to assess the utility of Gel as a novel tablet binder. Optimization of the formulation was done by adopting factorial design as an appropriate DOE. Tablets of factorial batches were evaluated for disintegration time and crushing strength. The effect of viscosity of binder solution used to prepare granulation and compression pressure applied on granulation on the performance of the tablets was confirmed by analyzing the data using ANOVA. Results: The addition of binder solution to prepare granulation with the viscosity ≥ 19.33 centipoises was found to be suitable to attain desired degree of agglomeration. The crushing strength of the tablets was found to be increased with an increase in compression pressure and an increase in viscosity of binder solution. Conclusion: The compatibility parameter was observed to be increased as the viscosity of the binder solution added in the formulation was gradually increased. The Gel as a binder material was found to deform plastically at compression pressures 34.48 to 75.85 MPa. This confirmed its functionality as a solution binder in Paracetamol tablet preparation.

Instant Drinks with Amaranth Flour: Simulation of Mechatronic Systems of Production

Introduction. The world market of instant drinks is a highly competitive environment. New mechatronic production systems can help food companies maintain their competitiveness: they determine process modes, analyze them, and choose the optimal parameters, thus increasing the efficiency of the whole food enterprise. Another problem is the low biological and nutrient value of the finished product. New biologically active instant drinks could solve the problem that occurs in conditions of unsocial hours and unbalanced diet. Products of plant origin contain a lot of useful substances. Amaranth flour increases the biological value of the final products. The research objective was to develop mechatronic systems that could be used to produce instant drinks fortified with amaranth flour at the granulation stage. Study objects and methods. The present research featured a new line of production of instant granular drinks fortified with amaranth flour. The study focused on the granulation section. A drum vibro-granulator with controlled segregated flows was used to make a hardware design of the granulation process. The granulation process often demonstrates an unstable particle size distribution, which is associated with non-uniform mixing of the dry bulk components with the binder solution. A mechatronic module can solve this problem. However, it requires detailed information about the process conditions. Results and discussion. The research determined the specific energy consumption on the operating and design parameters for the granulation process in the new drum vibro-granulator. The experiment made it possible to obtain the optimal process parameters and improve the quality of the finished product. The flow rate of the binder solution depended on the readings of the power consumed by the kneading body engine, which stabilized the system. The value of this parameter is so small that its direct regulation is technically impossible. The paper introduces a block diagram of a multi-circuit cascade system to control the quality of the mixture automatically. The authors installed a valve on the pipeline that feeds the binder fluid in the pressure tank. The valve made it possible to control the process with sufficient accuracy. Conclusion. In the new mechatronic module of the drum vibro-granulator, the quality indicators of the resulting mix depend on the amount of power consumed by the kneading body engine and on the level of the binder solution in the pressure vessel.

INFLUENCE OF BINDING SOLUTION CONCENTRATION, DRYING DURATION AND DRYING TEMPERATURE ON PHYSIOCHEMICAL PERFORMANCE OF NORFLOXACIN GRANULES AND TABLETS

Objective: To investigate the possible individual and joined influences that binding solution concentration, drying temperature and drying duration might have on the physiochemical attributes of granules and tablets using norfloxacin as a model drug. Methods: According to implemented 23 central composite designs, each of the investigated variables were examined at 5 different levels through different 16 formulation runs. For each formulation, obtained granules were qualified for their bulk density, tap density, Hausner ratio, percent of fine and drug content properties whereas the respective tablets were evaluated for their weight variation, drug content, friability, hardness, disintegration, and drug dissolution attributes. Results: Indicated that concentration of binder solution, as compared to drying temperature and drying duration, measured more profound influences on granules' tap density, Hausner ratio, % fine and drug content either through its individual linear and quadratic effects or through its joint effect with drying durations (p<0.05 at 95% CI for all influences). Whilst tablets' friability appeared to be noticeably influenced by the three investigated variables (P ranged 0.001-0.017 at 95% CI), tablets' hardness and disintegration were found to be considerably affected only by binder solution concentration (p = 0.001 and 0.082 at 95% CI, respectively). Moreover, none of the investigated variables has measured a significant influence on tablets' drug content or drug dissolution properties. Conclusion: The study concluded that quadratic and joint influences of variables on attributes of granule and tablet formulations shouldn't be overlooked and better to be considered in the screening design.

Systematic Scrutinisation of Vital Factors for Fabrication and Evaluation of PGS-MCC Based Drug Loaded Pellets by Extrusion Spheronization Technique

Objective: The prime objective was to formulate pellet formulation incorporating a newer extrusion- pelletisation aid, Pregelatinised Starch (PGS) and to scrutinise the factors that can affect the quality of the pellets and to overcome the slower disintegration of Microcrystaline Cellulose (MCC). Methods: Pellets were prepared initially using PGS, MCC, water, ethanol, HPMC K 4 M and Febuxostat was employed as model drug. Optimisation of formulation was done by employing Quality by design (QbD) and Design of experiment (DoE) approach. Ratio of PGS and MCC, ratio of binder and spheronisation speed were selected as independent variables and disintegration time and % cumulative drug release as dependent variables. In vitro in vivo correlation of the optimised batch was carried out using Wagner nelson method. Incompatibility studies have indicated compatibility of drug and excipients. Results: From the experiments, it was proved that the batch comprising 3:1 ratio of PGS and MCC, 1:1 binder solution and 1500 speed yielded good pellets with decreased disintegration time and improved dissolution rate as compared to pure Febuxostat. IVIVC studies indicated one to one correlation between in vitro and in vivo parameters. Conclusion: Pellets with good quality, minimum disintegration time and improved dissolution of model drug were successfully prepared with maximum amount of PGS. Optimisation using QbD approach was worth fruitful that affected the quality of pellets.

Pelletization Techniques. The Pharma Review

Pellets are spherical or nearly spherical, free-flowing granules with a narrow size distribution, typically varying between 500 and 1500 µm for pharmaceutical applications. They are generally produced via a pelletization process whereby a powder blend consisting of an API and excipients particles is agglomerated into spherical granules. This review article deals with various aspects of the extrusion–spheronization technique. Pelletization is a technique to convert drugs or excipients to small free flowing, spherical or semi spherical units, which are produced by agglomerating fine powdered drugs/ excipients with a binder solution. Pellets range in size, typically, between 0.5 – 2 mm. In relation to pharmaceuticals, pellets offer high degree of flexibility in design and development of oral dosage form. Pelletization technique help in the formation of spherical beads or pellets having a diameter 0.5 -1.5 mm which can be eventually coated for preparation of modified release dosage form. The manufacturing techniques include Drug layering, Extrusion-Spheronization, Cryopelletization, Compression, Balling, Hot-Melt Extrusion Technology, Freeze pelletization, Spray-drying & Spray-congealing. Factors affecting pelletization technique and advantages, disadvantages of pellets are discussed.

PENGARUH PENGGUNAAN PATI KULIT NANAS (Ananas comosus (L.) Merr.) SEBAGAI BAHAN PENGIKAT PADA GRANUL CTM

ABSTRACTThe biggest component found in pineapple peel are water and starch. One of the excipient that usually used in granule is starch that can used as disintegrant, filler and binder. This study aims to formulate and evaluate granule preparations with Pineapple peel starch binder at concentration of 4%, 6%, 8% and 10%. The Pineapple peel dried with oven and then mashed up with blender and precipitated in water until obtained starch. The Pineapple peel starch made as a binder in four formulations of granule based on different concentrate of Pineapple peel starch, they are F I 4%, F II 6%, F III 8% and F IV 10%. The Granules made by method of wet granulation by adding binder solution of pineapple peel starch to four formulations, and then dried and evaluated. The result evaluation of organoleptic gave the best result in formula III and IV, flow time of each formula has time a flow time that not too far different, 5.04-5.57 seconds, angle of repose in formula I-IV meet the requirements and formed the smallest angle in formula I 28°, real density of each formula about 1.09-1.82 g/ml and meet the requirements because they are bigger than water density, while the moisture content and loss on drying doesn’t meet the requirements because has high water content. The conclusion is Pineapple peel starch can’t be used as a binder in CTM granule. Keywords : Pineapple, Starch, Binder, Granules, Wet Granulation ABSTRAKKomponen terbesar yang terdapat dalam kulit Nanas ialah air dan pati. Salah satu bahan tambahan yang sering digunakan dalam pembuatan granul ialah pati yang dapat berfungsi sebagai bahan penghancur, bahan pengisi dan bahan pengikat. Penelitian ini bertujuan untuk memformulasikan dan mengevaluasi sediaan granul CTM dengan bahan pengikat pati kulit Nanas pada konsentrasi 4%, 6%, 8% dan 10%. Kulit nanas dikeringkan dengan oven kemudian dihaluskan dengan blender dan diendapkan dalam air sampai diperoleh butiran pati. Pati kulit Nanas dibuat sebagai bahan pengikat pada empat formulasi granul berdasarkan konsentrasi pati kulit Nanas yang berbeda yaitu F I 4%, F II 6%, F III 8% dan F IV 10%. Granul dibuat dengan metode granulasi basah yaitu dengan menambahkan larutan pengikat pati kulit Nanas pada empat formulasi, kemudian dikeringkan dan dievaluasi. Hasil evaluasi organoleptis memberikan hasil terbaik pada formula III dan IV, waktu alir dari tiap formula memiliki waktu yang tidak jauh berbeda yaitu 5,04-5,57 detik, sudut diam pada formula I-IV memenuhi persyaratan dan membentuk sudut terkecil pada formula I yaitu 28°, BJ sejati dari tiap formula berkisar dari 1,09-1,82 g/ml sehingga memenuhi persyaratan karena lebih besar dari BJ air, porositas dari formulasi I-IV memenuhi persyaratan yang memiliki range 46%-67,4%, sedangkan pada kandungan lembab dan kadar air tidak memenuhi persyaratan karena memiliki kandungan air yang terlalu tinggi. Kesimpulannya pati kulit Nanas tidak dapat digunakan sebagai bahan pengikat pada granul CTM.Kata Kunci : Nanas, Pati, Bahan Pengikat, Granul, Granulasi Basah