• Journal of Pharmaceutical Investigation
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• v.22 no.1
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• pp.49-54
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• 1992

This study was carried out for the purpose of developing an effective temazepam soft elastic gelatin capsule (softgel) which exhibits an excellent bioavailability and of comparing the rate and extent of absorption of temazepam from the marked elixir and prepared softgel using hydrophilic liquid such as polyethylene glycol 400 as a suspending agent by rotary die method. Both softgel and elixir containing 3 mg of temazepam were given to 7 healthy male New Zealand White rabbits in a single oral dose cross-over study. Plasma temazepam concentrations were measured by HPLC. The mean peak concentrations of temazepam following a single oral dosing as softgel and elixir dosage form were 13.84 and 13.25 ng/ml, respectively. And the mean time to peak concentration was 1.29 hr for the softgel and 1.07 hr for the elixir. There was no significant difference in the extent of drug absorption (AUC) for the two different dosage froms (p>0.05). While the softgel exhibited mean lag time of 0.63 hr, the elixir did not show any lag time. Statistical moment parameters such as the mean residence time and variance of the mean residence time did not differ significantly for the two formulations.

• YAKHAK HOEJI
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• v.59 no.2
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• pp.70-76
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• 2015

A Softgel is an oral dosage form for medicine similar to capsules and softgel dosage form offers several advantages over other oral dosage forms, such as delivering a liquid matrix designed to solubilize and improve the oral bioavailability of a poorly soluble compound as a unit dose solid dosage form, delivering low and ultra-low doses of a compound. This study aimed to qualify a proprietary vegetable soft capsule which contains modified starch and carrageenan as capsule shell components compare to the conventional gelatin softgel. Four kinds of samples were prepared with vegetable and gelatin capsule shell, respectively. Morphology of capsule shell, mechanical strength of capsule, and hygroscopic properties were studied for comparing the quality attributes of softgel. Short-term stability against heat and moisture was also investigated in this study. Vegetable capsule shell showed better mechanical strength, physical stability and disintegration time for temperature and humidity than those of conventional gelatin capsule shell with four different filling materials used frequently as soft capsule form. Conclusively, this vegetable capsule shell polymer system can replace easily gelatin-shell systems and additionally allows encapsulation of lipid fills at high temperatures that are semisolid or solid-like at room temperature.

• YAKHAK HOEJI
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• v.36 no.6
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• pp.598-603
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• 1992

The purpose of this study was to assess the effect of three formulations; product A (polyethylene glycol was used as a main dispersing agent), product B (wax mixture was used as a main dispersing agent) and product C(silicon dioxide was used as a main dispersing agent) on bioavailability of acetaminophen soft gelatin capsules(softgels) and to develop an effective acetaminophen softgel which exhibits an excellent bioavailability. Acetaminophen softgels of various formulations were prepared as 4 minim round type by rotary die method. Four softgels of the three formulation (A, B, C), each of which contained 50 mg acetaminophen, were administered orally to 12 normal healthy rabbits using a three-way cross over design. Plasma acetaminophen concentrations were measured by HPLC. The results obtained in this study were as follows: 1. The Tmax rank order of acetaminophen softgel was C$(63.75{\pm}10.62\;min)$>A$(36.25{\pm}5.37\;min)$>B$(35{\pm}6.74\;min)$. 2. The decreasing Cmax order of softgel product was A$(93.51{\pm}0.55\;{\mu}g/ml)$>B$(3.16{\pm}0.37\;{\mu}g/ml)$>C$(2.6{\pm}0.55\;{\mu}g/ml)$. 3. The $[AUC]^{\infty}_0$ rank order for three acetaminophen softgel formulations was A $(14.89{\pm}1.56\;{\mu}g/ml{\cdot}min)$ >B$(14.39{\pm}1.43\;{\mu}g/ml{\cdot}min)$>C$(11.45{\pm}1.49\;{\mu}g/ml{\cdot}min)$. 4. Pharmacokinetic parameters such as Tmax, Cmax and $[AUC]^{\infty}_0$ of product A and B did not differ significantly(p>0.05). On the other hand, those of product C were significantly different(p>0.05).