Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|Title:||Optimized formulation of tobramycin for aerosolization|
|Abstract:||The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.|
|Inventor(s):||Malvolti; Chiara (Parma, IT), Garzia; Raffaella (Parma, IT)|
|Assignee:||Chiesi Farmaceutici S.p.A. (Parma, IT)|
1. An aerosol formulation consisting of 75 mg/ml of tobramycin dissolved in an aqueous solution containing 0.45% sodium chloride; wherein the pH is between 4.0 and 5.5 and
the osmolarity ranges between 250 and 450 mOsm/l.
2. The aerosol formulation according to claim 1, wherein the pH is 5.2 and the osmolarity is between 280 and 350 mOsm/l.
3. A process for the preparation of an aerosol formulation according to claim 1, comprising: i) preparing an aqueous solution containing 0.45% w/v of sodium chloride; ii) adjusting the pH with a concentrated strong acid; iii) adding the active ingredient and mixing to complete dissolution; iv) re-adjusting the pH to the desired value; v) filling the solution in suitable container.
4. The process according to claim 3, wherein the solution is pre-sterilized by filtration.
5. The aerosol formulation according to claim 1, wherein said osmolarity is 280 to 350 mOsm/l.
6. The process according to claim 3, wherein the concentrated strong acid is sulfuric acid.
7. The process according to claim 3, wherein step ii) the pH is adjusted to 4.0 to 5.5.
8. The process according to claim 3, wherein in step iv) the pH is re-adjusted to 4.0 to 5.5.
9. The process according to claim 3, wherein said container is a multidose vial.
10. The process according to claim 3, wherein said container is a pre-sterilized unit vial of 2 ml.
11. The process according to claim 3, wherein said container is a pre-sterilized unit vial of 4 ml.
12. The process according to claim 3, wherein said filling in step v) is carried out under an inert atmosphere.
13. The aerosol formation according to claim 1, which is stable for at least 9 month at room temperature.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.