Sz. Swidan et al., ABILITY OF 2 COMESTIBLE FORMULATIONS OF HYDROXYPROPYLMETHYLCELLULOSE TO LOWER SERUM-CHOLESTEROL CONCENTRATIONS, European journal of pharmaceutical sciences, 4(4), 1996, pp. 239-245
High molecular weight hydroxypropylmethylcellulose (HPMC) is a water-s
oluble cellulosic ether that has recently been shown to reduce serum c
holesterol levels when administered as a diet Jell-O(R) formulation. F
or long term therapy, it would be desirable to formulate HPMC into a p
alatable, portable formulation. In this study, the ability of HPMC to
lower cholesterol levels was compared between cookie and diet Jell-O(R
) formulations. A randomized, double-blind cross-over placebo controll
ed study was conducted at the General Clinical Research Centre within
the University of Michigan Medical Centre. Twelve healthy, mildly hype
rcholesterolemic individuals participated in the three one-week phases
: HPMC in a cookie formulation, HPMC in a diet Jell-O(R) formulation a
nd a placebo formulation. Dietary intake was reproduced exactly in eac
h phase. Total cholesterol levels were reduced by 14+/-8% (P<0.05) aft
er one week of administration of HPMC in the cookie formulation and 19
+/-7% (P<0.05) using the diet Jell-O(R) formulation, compared to place
bo. LDL cholesterol levels were reduced by 19+/-13% (P<0.05) and 26+/-
6% (P<0.05), respectively. In vitro and canine experiments suggested t
hat the tendency to smaller reductions in total and LDL cholesterol le
vels achieved with the cookie formulation were associated with the slo
wer development of viscosity in solution, Notwithstanding the slightly
less impressive clinical results, the cookie formulation offers a pal
atable, portable and effective alternative to the diet Jell-O(R) formu
lation of HPMC.