Formulation of taste masked oro-dispersible tablets of ambroxol hydrochloride

D P Venkatesh, C G Geetha Rao1

Abstract


Ambroxol hydrochloride (HCL) is a potent mucolytic capable of inducing bronchial secretion. It is used in the treatment of asthma, bronchitis, and cough. But it is a very bitter drug and slightly soluble in water.Thus, in the work under taken,
an attempt was made to mask the taste and to formulate into a oro-dispersible tablet by complexation with ion exchange resins, which also acts as super disintegrating agents. Since, these tablets can be swallowed in the form of dispersion, it is suitable dosage form for pediatric and geriatric patients. Cation exchange resins like Indion-204 and Indion-234 were utilized for the sorption of drug. Drug-resinates were prepared in drug to resin ratio of 1:5 and 1:6. The prepared tablets were evaluated for general appearance, content uniformity, hardness, friability, taste evaluation, mouth feel, wetting time, in vitro and in vivo disintegration time, and in vitro dissolution studies. Tablets with both the resins have shown quick disintegrating features, i.e., within 20 s, which is very characteristic of oro-dispersible tablets. Also, the dispersion not showing any bitter taste, indicate the capability of ion exchange resins used, both as taste masking and super disintegrating agents. Almost more than 90 percent of drug was released from both the formulations within 1 h. Further formulations were subjected to stability testing for 3 months at temperatures 25±5oC/60±5%RH and 40±5oC/75±5%RH. Both tablets have shown no appreciable changes with respect to taste, disintegration, and dissolution profiles.


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References


Lachman, Liberman HA, Anig JL. Theory and practice of industrial

pharmacy. 3rd ed. Mumbai: Varghese Publishing House; 1991. p.

-302.

Bi Y, Sunada H, Yonezawa Y, Danjo K, Otsuka A, Iida K. Preparation

and evaluation of a compressed tablet rapidly disintegrating in the

oral cavity. Chem Pharm Bull (Tokyo) 1996;44:2121-7.

Indian pharmacopoeia, Govt of India, ministry of health and family

welfare. New Delhi: The Controller of Publications; 1996. Appendix

112, 736.

Wen, Betty, Ramsay, Michael P, Scheurer, Hein Rich Dokuzovic, et

al. Antussive drugs delivered by ion exchange resins. U.S patent

;6:001:392.

Kohli DP, Shan DH. Drug formulation manual. Eastern Publishers;

p. 367-8.

Avari JG, Bhalekar M. Cation exchange resin for taste masking and

rapid dissolution of Sparfloxacin. Indian Drugs 2003;4:19-23.

Hiremath JG, Shastry CS, Srinath MS. Pharmaceutical approaches of

taste masking in oral dorage forms. Indian Drugs 2004;41:253-7.

Tripati KD. Essentials of medical pharmacology. 5th ed. New Delhi:

Jaypee Brothers Medical Publisher; 2003. p. 196.

Chaudhari PD, Chaudhari SP, Lanke SD, Patel N. Formulation and

in vitro evaluation of taste masked orodispersible dosage form of

Levocetirizine. Indian J Pharm Educ Res 2007;41:319-28.

Chatap VK, Sharma DK, Middha A, Gupta RD, Saini V, Shiradkar M, et

al. Mouth disintegrating tablets of taste-masked ondansetron HCl.

Asian J Chem 2007;19:3455-60.9.

Available from: http://www.venpetro.com/Ambroxol hydrochloride.

RO - CEP 2004-240-Rev 00. htm

Sayed MS, Ulviya G, Bajaj AN. Oral controlled release Bromohexine

ion exchange resinate suspension formulation. Indian Drugs

:185-9.

Nanda AR, Kandarapu, Garg S. An update on taste masking technologies for oral pharmaceuticals. Indian J Pharm Sci 2002;64:10-7.

Geetha Rao CG, Motiwale AV, Satyanarayana D, Subrahmanyam EV.

Formulation of taste masked oral suspension of quinine sulphate by

complexation. Indian J Pharm Sci 2004;66:329.




DOI: http://dx.doi.org/10.22377/ajp.v2i4.192

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