Evaluation of the viability of Lactobacillus spp. after the production of different solid dosage forms.
The work aims to provide evidence on the viability of Lactobacillus spp. and a spore form of Bacillus subtilis from nonprocessed bacteria to coated dosage forms (i.e., mini-tablets, pellets, and their coated forms). Lactobacillus spp. were cultivated overnight in MRS broth (10(9) cfu/mL) and B. subtilis spores were produced on plate count agar (10(7) cfu/mL) for 2 weeks. Bacteria and spores were freeze-dried in skim milk enriched with glycerol. The cakes were further processed into tablets (2.5 mm diameter) by direct compression with or without microcrystalline cellulose and inulin. Pellets (1-1.4 mm diameter) were produced by extrusion-spheronization of bacterial and spore suspensions with microcrystalline cellulose, lactose, inulin, and skim milk. Both tablets and pellets were film coated. The properties of the dosage forms, particularly the bacterial viability, were evaluated immediately after production and throughout storage for 6 months at 4 degrees C. The study has shown that for an adequate stabilization of the bacteria a protective matrix (e.g., skim milk) and cryoprotectors (e.g., glycerol) must be present at early stages of bacterial de-hydration. Tabletting had a less deleterious effect (<2 log units) on bacteria when compared to pelletization (in some cases 3 log units). Enteric coating (15%, w/w) of either tablets or pellets did not affect the viability of the bacteria.
Brachkova
Mariya I
MI
iMed.UL - Research Institute for Medicines and Pharmaceutical Sciences, Faculdade de Farmácia da Universidade de Lisboa, Av. Prof. Gama Pinto, P-1649-003 Lisboa, Portugal.
Duarte
Aida
A
Pinto
João F
JF
D000818:Animals; D001412:Bacillus subtilis / Q000502:physiology*; D005079:Excipients; D005612:Freeze Drying; D005990:Glycerol; D007778:Lactobacillus / Q000502:physiology*; D050296:Microbial Viability; D008892:Milk; D013171:Spores, Bacterial; D013607:Tablets
D005079:Excipients; D013607:Tablets; D005990:Glycerol