scholarly journals PREFORMULATION STUDIES USING LACTOSE IN DEVELOPMENT OF SOLID ORAL DOSAGE FORM: A GRAPHICAL REPRESENTATION USING SeDeM METHOD

Author(s):  
Imran Tadwee ◽  
Sadhana Shahi ◽  
Zahed Zaheer

Objective: The objective of the study is to evaluate and present lactose scientifically as an excipient of choice in formulation development of solid orals dosage form for direct compression method. Present work will establish the ability of lactose as an excipient to be the choice of candidate while developing formulation having poor flow API using direct compression process. In addition to this different type of lactose is processed using secure development method (SeDeM) in order to evaluate best suitable type of lactose amongst its different type.Methods: Lactose anhydrous, lactose monohydrate and Lactose spray dried (SD) were employed for evaluation using SeDeM method, twelve different selected pharmacotechnical parameters were determined experimentally and were treated mathematically and expressed in the graphical representation as SeDeM diagram. Parameter index, parameter profile index and good compression index values were calculated.Results: Good compression index was found to be 6.06,5.72,6.83 parameter index was 0.25, 0.42, 0.17 and parameter profile index found to be 6.36,6.01,7.18 for lactose anhydrous, lactose monohydrate and Lactose SD respectively.Conclusion: This research work reveals that data obtained will be useful for the pharmaceutical industries while formulating the drug product and will reflect the scientific characteristics of this excipient as well. This will enable the availability of values obtained after performing SeDeM studies on lactose to scientific society based on the results researchers can use establised data and statistics in their pre-formulation studies to incorporate lactose with confidence and can be justified scientifically in the development formulation of the direct compression process and API having poor flow. Results indicating good direct compression characteristics of the all 3 type of lactose, and Lactose SD can be preferred amongs these 3 types. 

2021 ◽  
Vol 10 (4) ◽  
pp. 94-101
Author(s):  
Ranjitha M T ◽  
C N Somashekhar

A new dosage form, Oral disintegrating tablets (ODT’s) as a replacement to conventional oral dosage forms. ODT’s are dosage forms they disintegrate in mouth offering various advantages such as better mouth feel, dose accuracy, improved stability and convenient dosing as compared to oral liquids. So, there is need to designed oral disintegrating tablet to release the medicaments with an enhanced rate. Mefenamic acid is an anti- inflammatory drug while Dicyclomine HCl is anti-cholinergic drug. The combination of Mefenamic acid & Dicyclomine HCl controls pain very effectively, also relaxes bodily spasm which commonly arises during menstruation or intestinal colic spasm. This combination gives the quick onset of action and fast relief than conventional dosage form. For preparation of oral disintegrating tablet nine formulations were designed using Croscarmellose sodium and Crospovidone as superdisintegrants in varying concentration. All the formulations were prepared by direct compression method. Thus, all the formulations of Mefenamic acid and Dicyclomine HCl oral disintegrating tablets were investigated, in which F9 formulation was optimized. The % drug release of, Oral disintegrating tablet batch F9 has shown 96.98% of Mefenamic acid and 94.02 % of Dicyclomine HCl in 18 min, disintegration time in 40 sec and wetting time in 25sec.


Author(s):  
Kusuma P. ◽  
Syukri Y ◽  
Sholehuddin F. ◽  
Fazzri N. ◽  
Romdhonah . ◽  
...  

The most efficient tablet processing method is direct compression. For this method, the filler-binder can be made by coprocessing via spray drying method. The purpose of this study was to investigate the effect of spray dried co-processing on microcrystalline cellulose (MCC) PH 101, lactose and Kollidon® K 30 as well as to define the optimum proportions. Spray dried MCC PH 101, lactose, and Kollidon® K 30 were varied in 13 different mixture design proportions to obtain compact, free-flowing filler-binder co-processed excipients (CPE). Compactibility and flow properties became the key parameters to determine the optimum proportions of CPE that would be compared to their physical mixtures. The result showed that the optimum proportion of CPE had better compactibility and flow properties than the physical mixtures. The optimum CPE, consisting of only MCC PH 101 and Kollidon® K 30 without lactose, that were characterized using infrared spectrophotometer, differential scanning calorimetry (DSC), X-ray diffraction (XRD), and scanning electron microscope (SEM) indicated no chemical change therein. Therefore, this study showed that spray dried MCC PH 101, lactose and Kollidon® K 30 could be one of the filler-binder alternatives for direct compression process.


2020 ◽  
pp. 18-21
Author(s):  
E. Blynskaya ◽  
S. Tishkov ◽  
V. Bueva ◽  
K. Alekseev ◽  
V. Alekseev ◽  
...  

Medicated chewing gum is a convenient dosage form that allows to expand the range of medicines, ensure adherence of patients to the treatment and extend patent protection for well-known names of medicines. This article describes the technological properties of the Health in Gum® chewing gum base, which provides medicinal chewing gums with minimal addition of excipients by direct compression.


Processes ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. 26
Author(s):  
Teodora Balaci ◽  
Bruno Velescu ◽  
Oana Karampelas ◽  
Adina Magdalena Musuc ◽  
George Mihai Nițulescu ◽  
...  

The aim of our study was to obtain rutoside (RUT) inclusion complexes in β-cyclodextrin (β-CD) and in hydroxypropyl-β-cyclodextrin (HP-β-CD), in a 1:1 molar ratio, using the lyophilization method of complexation in solution. The complexes were confirmed and characterized, in comparison with the raw materials and their simple physical mixtures, by SEM, DSC, and FT-IR analyses. The antioxidant activity of the compounds was assessed by using the 2,2-diphenyl-1-picryl-hydrazyl (DPPH) and 2’-azino-bis(3-ethylbenzothiazolin-6-sulfonic) acid (ABTS) radicals, determining the radical scavenging activity, and by ferric reducing antioxidant power (FRAP) assay. The results revealed superior antioxidant ability for the inclusion complexes towards rutoside alone. The inclusion complexes were used as active ingredients in formulations of immediate-release tablets. The preformulation studies were performed on the powders for direct compression obtained after mixing the active ingredients with the excipients (Avicel PH 102, Polyplasdone XL-10, magnesium stearate, and talc). The materials were assessed for particle size, flowability, compressibility, and moisture content, establishing they are suitable for a direct compression process. The tablets were characterized regarding their pharmaco-technical properties and the results proved that the formulations lead to high-quality delivery systems, showing a good mechanical resistance with a low friability, excellent disintegration times, and satisfying dissolution rate. The performances were very similar for both formulations and the physico-mechanical properties of the tablets are not influenced by type of the used cyclodextrin, but the RUT- HP-β-CD tablets presented a higher dissolution rate.


1978 ◽  
Vol 12 (12) ◽  
pp. 720-727
Author(s):  
T. Donald Rucker ◽  
Leonard Janis ◽  
Marialice Bennett

This pilot study describes and suggests quality of care considerations related to prescriptions ordered by podiatrists for ambulatory patients. During the four-month survey period, the average podiatrist initiated 120 prescription orders and utilized 26 different drug entities. The 44 practitioners employed 235 different preparations, headed by Lotrimin®, Mepergan Fortis® and erythromycin. Although refill orders were judged as conservative, questions are raised about the use of oral dosage form combination products, agents employed infrequently, and the desired therapeutic intention of some preparations.


Author(s):  
Harmanpreet Singh ◽  
Pooja Jaiswal ◽  
Suksham Gupta ◽  
Simerjit Singh

  Objective: The current investigation deals with formulation and evaluation of fast disintegrating sublingual tablets of rizatriptan benzoate (RTB) to produce its intended therapeutic effect for acute treatment of migraine. When the drug is given by sublingual route, it overcomes the first pass metabolism and quick entry of drug in systemic circulation is obtained. It would result in fast pharmacological response hence faster relief from migraine which is an important criterion in migraine therapy.Methods: In this study, RTB sublingual tablets were prepared using direct compression process using various bioadhesive polymers such as sodium carboxymethyl cellulose, hydroxyl propyl methyl cellulose-K4M, and chitosan at various concentration ranging 0.5-5% w/w along with sodium starch glycolate (SSG) or cross carmellose sodium (CCS) as super disintegrants at different concentration ranging 2-8% w/w.Results: The tablets disintegrated quickly and dissolution tests conclude that RTB was released from the formulation within the compendial limits. The formulations batches (A8 and B8) containing 2% w/w chitosan along with 2% w/w SSG or CCS which disintegrate rapidly and show high dissolution and ex vivo permeation were selected as optimized formulations.Conclusion: The results obtained from the study showed that the bioavailability problem of the drug has been solved as the drug is given by sublingual route and it directly enters into systemic circulation. Furthermore, the formulation overcomes the problems associated with migraine attack as fast disintegrating technology is used.


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