PMID- 15760069
OWN - NLM
STAT- MEDLINE
DCOM- 20051220
LR  - 20181113
IS  - 1530-9932 (Electronic)
IS  - 1530-9932 (Linking)
VI  - 5
IP  - 3
DP  - 2004 Apr 29
TI  - Preparation and evaluation of a novel buccal adhesive system.
PG  - e35
AB  - The aim of the present study was to prepare and evaluate a novel buccal adhesive 
      system (NBAS) containing propranolol hydrochloride (PH). A special punch was 
      fabricated and used while preparing an NBAS. Solubility of PH in phosphate buffer 
      solution (pH 6.6), partition coefficient between phosphate buffer (pH 6.6) and 
      1-octanol, and permeability coefficient through the porcine buccal mucosa were 
      performed and found to be 74.66 mg/mL, 5.17, and 5.6, respectively. Stability of 
      NBAS was determined in natural human saliva, and it was found that both PH and 
      device are stable in human saliva. NBAS was evaluated by weight uniformity, 
      thickness, hardness, friability, swelling, mucoadhesive strength, in vitro drug 
      release, and in vivo human acceptability studies. Swelling index was higher (4.4) 
      for formulations containing hydroxyl propyl methyl cellulose (HPMC) K4M alone, 
      and it decreases with its decreasing concentration in the NBAS. Mucoadhesive 
      strength (MS) was measured by using a modified apparatus. All NBASs showed higher 
      MS with porcine buccal mucosa when compared with that of rabbit buccal mucosa. 
      NBASs containing carbopol (CP) 934P and HPMC K4M at the ratio of 1:1 showed 
      higher MS (44.76 g) with porcine buccal mucosa when compared with 1:2 (39.76 g), 
      0:1 (23.29 g), and 1:0 (22.22 g) ratios, respectively. The mechanism of PH 
      release was found to be by non-Fickian diffusion (value of "n" between 0.5 and 
      1.0) and followed first order kinetics. In vivo human acceptability study showed 
      that the newly prepared NBAS was comfortable in the human buccal cavity. It can 
      be concluded that NBAS is a superior, novel system that overcomes the drawback 
      associated with the conventional buccal adhesive tablet.
FAU - Desai, K Gh
AU  - Desai KG
AD  - Graduate School of Biotechnology, Korea University, 1, 5-ka, Anam-Dong, 
      Sungbuk-ku, Seoul-136-701, South Korea. kghdesai@yahoo.com.
FAU - Kumar, T Mp
AU  - Kumar TM
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20040429
PL  - United States
TA  - AAPS PharmSciTech
JT  - AAPS PharmSciTech
JID - 100960111
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Delayed-Action Preparations)
RN  - 9Y8NXQ24VQ (Propranolol)
SB  - IM
MH  - Adhesiveness
MH  - *Administration, Buccal
MH  - Adolescent
MH  - Adrenergic beta-Antagonists/administration & dosage
MH  - Adult
MH  - Animals
MH  - Cell Membrane Permeability
MH  - Delayed-Action Preparations
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mouth Mucosa/metabolism
MH  - Propranolol/administration & dosage
MH  - Rabbits
MH  - Solubility
PMC - PMC2750259
EDAT- 2005/03/12 09:00
MHDA- 2005/12/21 09:00
PMCR- 2005/04/29
CRDT- 2005/03/12 09:00
PHST- 2005/03/12 09:00 [pubmed]
PHST- 2005/12/21 09:00 [medline]
PHST- 2005/03/12 09:00 [entrez]
PHST- 2005/04/29 00:00 [pmc-release]
AID - 5301 [pii]
AID - 10.1208/pt050335 [doi]
PST - epublish
SO  - AAPS PharmSciTech. 2004 Apr 29;5(3):e35. doi: 10.1208/pt050335.