• Journal of Pharmaceutical Investigation
• /
• 제38권5호
• /
• pp.303-311
• /
• 2008

Highly hydrophobic lubricants including magnesium stearate may hinder water penetration into the tablet core resulting in delayed disintegration of fast disintegrating tablets. Alternative lubricants with equivalent lubricating properties may need to be incorporated into the tablet formulations. Sodium stearyl fumarate, glyceryl behenate and polyethylene glycol were evaluated regarding the tablet ejection energy, mechanical strength and disintegration time using Texture analyzer (TA). Resulting tablets were also compared with different particle sizes of granules and various compression forces. Among the tested lubricants, sodium stearyl fumarate was less sensitive to mixing time and also showed better or competitive tablet properties. During the experiments, TA was found to be very useful tool to investigate the tablet properties.

• Journal of Pharmaceutical Investigation
• /
• 제37권5호
• /
• pp.275-280
• /
• 2007

A rapidly disintegration famotidine tablet formulation in the oral cavity was developed using microcrystalline cellulose (MCC) and low-substituted hydroxypropyl cellulose (L-HPC), or additionally cropovidone as an internal disintegrant. Effects of disintegrants on the disintegration time in vitro and hardness were evaluated. Average wetting time of the tablets prepared in scale-up manufacturing process was less than 15 sec. Among the formulations tested, the tablet prepared with crospovidone as an internal disintegrant and Emcocel $90M^{(R)}$ as an external disintegrant showed fastest disintegration. These results may suggest that crospovidone and Emcocel $90M^{(R)}$ possessed excellent wetting nature, which result in the rapid disintegration of tablet.

• Journal of Pharmaceutical Investigation
• /
• 제39권6호
• /
• pp.445-449
• /
• 2009

According to the statistical data, stroke is about 13.9% of leading causes of death. Some herbal medicines including Paeonia lactiflora, Angelica gigas nakai and Prunus persica, etc., had been reported to be effective in preventing stroke and mBHT (Modified BoyangHwanoTang) was an advanced prescription used in Korean clinics. Orally disintegrating tablets (ODT) is useful for patients suffering from dysphagia, motion sickness, repeated emesis and mental disorders. Further, drugs exhibiting satisfactory absorption through the mucosa intended for immediate pharmacological action could be advantageously formulated in ODT. The aim of this study was to develop the most efficient ODT formulation of mBHT. Corresponding herbal medicines comprising mBHT were extracted with water for 3 hr at 95~$100{^{\circ}C}$ and then dried. mBHT extract was obtained with about 30% of yield. Subsequently, some pharmaceutical excipients such as spray-dried lactose, crospovidone, glyceryl behenate and/or cogrinded-treated arabia gum were used to achieve an immediate disintegration of mBHT ODT in oral cavity. The requirements of ODT with mechanical strength sufficient to stand the rigors of handling and capability of disintegrating within a few seconds in contact with saliva are indispensable. mBHT ODT prepared by the wet granulation method showed a disintegration time of below 30 sec.

• 한국분무공학회지
• /
• 제18권1호
• /
• pp.1-8
• /
• 2013

In this paper an experimental study is presented to investigate the dynamic behavior of impacting droplet onto a liquid film. The main parameters are the droplet velocity and the thickness of the liquid film. Photographic images are presented to show the formation of crown, central jet and disintegrating droplet from the central jet. The emphasis is on presenting the time evolution of crown diameter, crown height, central jet height and the size of disintegrating droplet from the central jet. The diameter and height of crown are higher for faster droplet and thinner liquid film. On the other hand, the height of central jet are higher for faster droplet and thicker liquid film. The size of disintegrating droplet from the central jet heavily depends on the droplet velocity; Larger droplet is produced with faster falling droplets.

• Journal of Pharmaceutical Investigation
• /
• 제41권1호
• /
• pp.51-57
• /
• 2011

The objective of this study was to enhance the utilitization of Ibuprofen (IBU) by introducing the fast-disintegrating tablet (FDT) form. Presently, IBU is being widely used as a tablet or syrup form. But in contrast to these two formulations, IBU as FDT is not only convenient but also increases the control over the time release of the drug, noted by using Alginate beads. This study was carried out with Sodium Alginate and IBU at the ratios of 1:0, 1:0.5, 1:1, and 1:2 in order to produce a series of beads with different ratios. During the drying process of the beads, talc was added in beads to compare the effects with and without the talc. The final product was scanned with SEM imaging to determine the difference in the surface of the beads. The parameters assessed were the diameter, content assay, dissolution test and effectiveness of time-release. Direct compression method was used to prepare FDT containing IBU bead. The properties of FDT, such as hardness, disintegration time, were investigated. The dissolution profiles of FDT were tested using KP dissolution apparatus 1 (basket method). The results suggest addition of talc and drying the beads made the surface smooth and less vulnerable to clutter into chunks. The size of beads was less than 300 ${\mu}m$ which did not create a sandy feeling in the mouth. Thus, the beads formulation model made the sustained release of the drug possible, the hardness of FDT (1.25~1.50 $Kg/cm^2$) was acceptable and all the values of dissolving period were less than 30 seconds. The dissolution profile of FDT was same as that of IBU bead. The efficient dissolution profile and low price of IBU bead containing Sodium Alginate, the FDT formulation prepared from IBU bead can save the expenses and can improve the convenience of application of this drug.

• 한국식품과학회지
• /
• 제54권3호
• /
• pp.327-333
• /
• 2022

칼슘과 함께 뼈 건강에 필수적이나, 그 섭취량이 부족하여 문제가 되고 있는 비타민 D를 쉽게 보충할 수 있는 새로운 제형으로 천연 고분자 물질인 히알루론산을 기반으로 한 비타민 D 함유 구강용해필름(orally disintegrating film, ODF)을 개발하고 비타민 D 함량에 따른 필름의 특성을 분석하였다. 첨가량은 2020 한국인 영양소섭취기준의 비타민 D 하루 충분섭취량(400IU: 10 ㎍)을 기준으로 4, 7배, 그리고 상한섭취량인 10배로 설정하였다. 제조한 필름의 두께는 기반물질의 농도가 가장 높은 대조군이 가장 두꺼웠고, 비타민 D 첨가량에 따른 유의적 차이는 없었다(p<0.05). 비타민 D 첨가군간 필름의 수분함량의 차이는 없었으며, 첨가량이 많아질수록 투습도는 다소 감소하는 경향을 보여 소수성 물질인 비타민 D가 영향을 미친 것으로 보인다. 비타민 D의 함량이 높아질수록 필름의 명도는 10AI만 유의적으로 높았으며, 적색도는 감소하고 황색도는 증가하였다(p<0.05). 이와 같은 색도특성은 첨가한 비타민 D 시료 자체 색의 영향을 받은 것으로 보인다. 대조군과 비교하였을 때 비타민 D의 증가는 불투명도를 유의적으로 증가시켰으며(p<0.05), 7AI와 10AI에서 가장 높은 불투명도를 보였다. 다른 친수성 고분자 필름과 달리 본 연구에서 제조된 히알루론산 기반 필름은 가소제의 첨가 없이도 타 연구의 필름에 비교하여 높은 인장강도(84.40-106.6 MPa)(p<0.05)와, 비슷한 수준의 연신율(4.71-9.43%)(p>0.05)을 갖는 질감 특성을 보였다. HPLC/MS 분석을 통해 필름 내의 실제 비타민 D 함량을 분석한 결과, 제조 과정 중 비타민 D의 손실이 발견되었으며 이로 인해 목표섭취량(2020 한국인 영양소섭취기준 비타민 D 충분섭취량)을 충족하기 위해서는 제조 기준의 1.5-2배를 섭취하는 것이 적절할 것으로 보인다. 본 연구에서는 생체물질인 히알루론산을 기반으로 비타민 D를 쉽게 섭취할 수 있는 새로운 제형을 개발하였으며, 비타민 D 첨가로 인한 필름의 특성이 향상되는 결과를 이용하여 구강용해용 뿐 아니라 가식성 포장재 등 다양한 활용이 가능할 것으로 제안하는 바이다.

• 한국응급구조학회지
• /
• 제24권2호
• /
• pp.89-97
• /
• 2020

Purpose: In this study we aimed to manufacture and evaluate an oral disintegrating film containing ibuprofen. Methods: Optimal oral ventilation was manufactured using ibuprofen 3g, polyvinyl alcohol #500 4.2g, HPMC K 100M 1.6g, glycerol 4g, TWEEN #20 0.3g, PEG #20 0.3g, citric acid 0.5g, sucralose 0.1g, ethamol 10mL, and distilled water 30mL. Results: Film mass ranged from 110 to 130mg in all prescriptions, showing general uniformity while the water content ranged from 6 to 12%. Measurement of ibuprofen content in all manufactured film solutions averaged 100.12% (98.0-102.0%). The elution test predicted the time taken from the body and the film agent of all prescriptions was released 100% within 5 minutes to confirm the rapid elution. Conclusion: Based on the results of all test, prescription E was proved to be the most suitable.

• Journal of Pharmaceutical Investigation
• /
• 제40권5호
• /
• pp.297-304
• /
• 2010

The present work focuses on preparation of olanzapine, orally dispersing tablets by direct compression method. Effect of super disintegrant crospovidone, disintegration time, drug content on in vitro release has been studied. A factorial design was employed in formulating a prompt dispersible tablet. The selected independent variables crospovidone and fmelt showed significant effect on dependent variables i.e. disintegration time and percent drug dissolved. Disintegration time and percent drug dissolved decreased with increase in the level of crospovidone. The similarity factor $f_2$ was found to be 97.48 for the developed formulation indicating the release was similar to that of the marketed formulation. Pharmacokinetics of olanzapine after single-dose oral administration of orally disintegrating tablet in normal volunteers were evaluated and the results showed that PK parameters (Cmax, Tmax, AUC) of the designed ODT matrix were similar to those of commercial product, Zyprexa Zydis$^{(R)}$ as a reference.

• Journal of Pharmaceutical Investigation
• /
• 제20권1호
• /
• pp.7-12
• /
• 1990

In case of the slowly disintegrating tablets such as enzyme preparations, disintegration time (DT) may be the important factor in formulating those preparations. The effects of tablet hardness, lubricants and disintegrants on DT were investigated in this approach. Disintegration time was significantly affected by disintegrants, moderately by lubricants, but not by tablet hardness. The effect was in the order of magnesium stearate >talc, PEG, sodium benzoate in case of lubricants, and of Ac-Di-Sol>LHPC>Primogel >Kollidon in case of disintegrants. Because lubricants and disintegrants influenced the tablet hardness and DT profile showed complicated pattern, it should be remembered that all factors mentioned above should be simultaneously considered in the formulation of enzyme tablets.

• KSBB Journal
• /
• 제31권4호
• /
• pp.291-299
• /
• 2016

In this study, Indomethacin, the poorly water soluble drug, was selected and prepared dispersing oral disintegrating films according to the molecular weight of polyethylene glycol (PEG) which are sort of dispersing agents. Also the molecular weight and content of PEG were evaluated effect on the degree of dispersion, physical property and dissolution when making oral dispersing film containing indomethacin to find appropriate condition and suggested guidelines of making oral dispersing film. The appropriate dispersing ratio of the amount of surfactants and dispersing agent were 1% and 4%, also the stability dropped in the PEG molecular weight of 4000 or more. Drying time of oral dispersing film was $90^{\circ}C$ for 10 minutes to 12 minutes that dispersing film's property about flexibility, detachability were very good. The oral dispersion film's content used PEG 400 was $98.6{\pm}0.5%$ and the most uniform. As the molecular weight of PEG increased, dissolution time also increased. On the basis of evaluation parameter, PEG with 400~600 of molecular weight was selected as good dispersing agent in oral dispersing film. Therefore, it can be suggested guideline of preparation application study in oral dispersing film.