Three-in-one low-dose tablet shows promise for optimum BP control

Segregation is a common problem in batch-based direct compression (BDC) processes, especially with low-dose tablet products, as is the preparation of a homogenous mixture. The scope of the current work was to explore if a continuous direct compression (CDC) process could serve as a solution for these challenges. Furthermore, the principle of a platform formulation was demonstrated for low dose tablets. The combination of filler excipients and the API in the formulation used was suitable for direct compression, but also prone to induce segregation in BDC process. The CDC process was found to be very promising; it was shown that tablets with the desired quality parameters could be manufactured successfully with both of the APIs studied. Powder analysis indicated that the APIs display some fundamental differences in their physical properties, which was also reflected in powder mixture properties and, hence, eventually in processing. However, process parameters, especially mixer impeller speed, were not found to have any significant influence on end product quality. The study suggests that a CDC process can be a viable solution to resolve the challenges described. Moreover, manufacturing by using a universal platform formulation seems to be a feasible way for producing low-dose tablets.

Download Full-text

Comparison of Low Shear, High Shear, and Fluid Bed Granulation During Low Dose Tablet Process Development

Drug Development and Industrial Pharmacy ◽

10.1081/ddc-120030419 ◽

2004 ◽

Vol 30 (3) ◽

pp. 259-266 ◽

Cited By ~ 25

Author(s):

Debra S. Hausman

Keyword(s):

Low Dose ◽

Process Development ◽

High Shear ◽

Fluid Bed ◽

Fluid Bed Granulation ◽

Dose Tablet ◽

Low Shear

Download Full-text

Harnessing ordered mixing to enable direct-compression process for low-dose tablet manufacturing at production scale

Powder Technology ◽

10.1016/j.powtec.2013.02.016 ◽

2013 ◽

Vol 239 ◽

pp. 290-299 ◽

Cited By ~ 9

Author(s):

Chen Mao ◽

Venkat R. Thalladi ◽

Derrick K. Kim ◽

Sarina H. Ma ◽

David Edgren ◽

...

Keyword(s):

Low Dose ◽

Direct Compression ◽

Compression Process ◽

Production Scale ◽

Tablet Manufacturing ◽

Dose Tablet

Download Full-text

Evaluation of low-dose tablet Buccilamine (Rimatils 50) in the treatment of active adult rheumatoid arthritis.

Ensho ◽

10.2492/jsir1981.13.187 ◽

1993 ◽

Vol 13 (2) ◽

pp. 187-194

Author(s):

Kiyoshi Takasugi ◽

Sumiki Yamamoto ◽

Nobuo Takubo ◽

Fumio Shinomiya

Keyword(s):

Rheumatoid Arthritis ◽

Low Dose ◽

Adult Rheumatoid Arthritis ◽

Dose Tablet

Download Full-text

Improving the Content Uniformity of a Low-Dose Tablet Formulation Through Roller Compaction Optimization

Pharmaceutical Development and Technology ◽

10.1080/10837450701369253 ◽

2007 ◽

Vol 12 (4) ◽

pp. 391-404 ◽

Cited By ~ 27

Author(s):

Mary T. am Ende ◽

Sara K. Moses ◽

Anthony J. Carella ◽

Rashmi A. Gadkari ◽

Timothy W. Graul ◽

...

Keyword(s):

Low Dose ◽

Tablet Formulation ◽

Roller Compaction ◽

Content Uniformity ◽

Dose Tablet

Download Full-text

Homogenization of Amorphous Solid Dispersions Prepared by Electrospinning in Low-Dose Tablet Formulation

Pharmaceutics ◽

10.3390/pharmaceutics10030114 ◽

2018 ◽

Vol 10 (3) ◽

pp. 114 ◽

Cited By ~ 4

Author(s):

Gergő Fülöp ◽

Attila Balogh ◽

Balazs Farkas ◽

Attila Farkas ◽

Bence Szabó ◽

...

Keyword(s):

Low Dose ◽

Solid Dispersions ◽

Amorphous Solid ◽

Electrospun Fibers ◽

Sieve Analysis ◽

High Shear ◽

Plastic Bags ◽

Shear Mixing ◽

Model Drug ◽

Dose Tablet

Low-dose tablet formulations were produced with excellent homogeneity based on drug-loaded electrospun fibers prepared by single-needle as well as scaled-up electrospinning (SNES and HSES). Carvedilol (CAR), a BCS II class compound, served as the model drug while poly (vinylpyrrolidone-co-vinyl acetate) (PVPVA64) was adopted as the fiber-forming polymer. Scanning electron microscopy (SEM) imaging was used to study the morphology of HSES and SNES samples. Different homogenization techniques were compared to maximize homogeneity: mixing in plastic bags and in a high-shear granulator resulting in low-shear mixing (LSM) and high-shear mixing (HSM). Drug content and homogeneity of the tablets were measured by UV-Vis spectrometry, the results revealed acceptably low-dose fluctuations especially with formulations homogenized with HSM. Sieve analysis was used on the final LSM and HSM powder mixtures in order to elucidate the observed differences between tablet homogeneity. Tablets containing drug-loaded electrospun fibers were also studied by Raman mapping demonstrating evenly distributed CAR within the corpus.

Download Full-text

Ovarian Dysfunction in Fetally Irradiated Beagles

Proceedings, annual meeting, Electron Microscopy Society of America ◽

10.1017/s0424820100080717 ◽

1977 ◽

Vol 35 ◽

pp. 658-659

Author(s):

T. M. Seed ◽

M. H. Sanderson ◽

D. L. Gutzeit ◽

T. E. Fritz ◽

D. V. Tolle ◽

...

Keyword(s):

Gamma Rays ◽

Low Dose ◽

Long Term Effects ◽

Ovarian Dysfunction ◽

Dose Rates ◽

Highly Sensitive ◽

Microscopic Evaluation ◽

Ovarian Pathology ◽

Normal Offspring

The developing mammalian fetus is thought to be highly sensitive to ionizing radiation. However, dose, dose-rate relationships are not well established, especially the long term effects of protracted, low-dose exposure. A previous report (1) has indicated that bred beagle bitches exposed to daily doses of 5 to 35 R 60Co gamma rays throughout gestation can produce viable, seemingly normal offspring. Puppies irradiated in utero are distinguishable from controls only by their smaller size, dental abnormalities, and, in adulthood, by their inability to bear young.We report here our preliminary microscopic evaluation of ovarian pathology in young pups continuously irradiated throughout gestation at daily (22 h/day) dose rates of either 0.4, 1.0, 2.5, or 5.0 R/day of gamma rays from an attenuated 60Co source. Pups from non-irradiated bitches served as controls. Experimental animals were evaluated clinically and hematologically (control + 5.0 R/day pups) at regular intervals.

Download Full-text