Mahesh M
★    

India,
2014-11-27 09:05
(3409 d 17:41 ago)

Posting: # 13925
Views: 4,107
 

 Orally inhaled products [Regulatives / Guidelines]

Dear All,

My concern regarding the bioequivalence study of Orally inhaled products. Can anyone enlighten me for the same?
Any special clinical facility (dosing area ) is required to perform BE study of OIPs ?
And what’s about the Retention sample for the same?

Regards
Dr_Dan
★★  

Germany,
2014-11-27 09:32
(3409 d 17:14 ago)

@ Mahesh M
Posting: # 13926
Views: 3,567
 

 Orally inhaled products

Dear Mahesh M
Orally inhaled products are complicated products and the assessment of BE is not easy. ElMaestro is an expert in the field of orally inhaled products. Wait for his answer in this forum or contact him directly (see Homepage http://www.fuglsangpharma.com/).
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
Mahesh M
★    

India,
2014-11-27 14:40
(3409 d 12:06 ago)

@ Dr_Dan
Posting: # 13931
Views: 3,542
 

 Orally inhaled products

Hello Dr. Dan

Orally inhaled products are complicated products and the assessment of BE is not easy.

I do agree.

❝ ElMaestro is an expert in the field of orally inhaled products. Wait for his answer in this forum or contact him directly (see Homepage http://www.fuglsangpharma.com/).


Hi ElMaestro,

W8ing for your responce.

Regards
priya
☆    

India,
2014-11-28 09:02
(3408 d 17:44 ago)

@ Mahesh M
Posting: # 13940
Views: 3,532
 

 Orally inhaled products

Hi Mahesh,

❝ My concern regarding the bioequivalence study of Orally inhaled products. Can anyone enlighten me for the same?


When testing for the bioequivalence of orally inhaled anti-asthmatic drugs, such as new formulations, new inhalation devices or new propellants, special problems may arise that make conventional bioequivalence studies inappropriate. In these circumstances therapeutic equivalence must be shown.

Pharmacodynamic studies may be sufficient to support a claim of equivalence of two inhaled bronchodilators. For other classes of anti-asthmatic drugs clinical efficacy and safety studies are generally required to show therapeutic equivalence. Comparative studies of in vitro inhaler performance, in vivo lung deposition and pharmacokinetics have yet to be validated as surrogates of the safety and efficacy of inhaled anti-asthmatic agents. Pharmacokinetic data are useful to assess systemic safety.

For more detailed information regarding the bioequivalence issue of orally inhaled products the following guidances should be considered:

"Replacement of Chlorofluorocarbons (CFCs) in Metered Dose Inhalation Products" (75/318/EEC - Council Regulation No. 594/91)
"Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma" (CPMP/EWP/2922/01)
"Clinical Requirements for Locally Applied, Locally Acting Products, Containing Known Constituents" (CPMP/EWP/239/95)

❝ And what’s about the Retention sample for the same?


As per FDA's Handling and Retention of BA and BE Testing Samples, For ANDAs, at least 50 units of each of three batches should be retained for each of the test articles and reference standards used for in vivo or in vitro BE studies. If multiple testing facilities are used in a BA or BE study, the total amount of reserves for each product across all testing facilities would be at least 50 units, and each testing facility should retain a reasonable amount of test articles and reference standards.

Priya.
Mahesh M
★    

India,
2014-11-28 12:20
(3408 d 14:26 ago)

@ priya
Posting: # 13946
Views: 3,446
 

 Orally inhaled products

Hi Priya,

Thanks for your response.


Can u suggest me about below points?

How can we control the variability of OIPs and DPIs

It is very typical to collect the blood sample at close sampling time points (when you give more than one Puff and dosing instruction says that the gap between two puffs should be 30 sec)

Is it required to maintain 30 sec gap between each puff


Any specific requirements for dosing area or clinical facility?

Regards
PharmaScience15
☆    

2015-01-08 01:05
(3368 d 01:41 ago)

@ priya
Posting: # 14242
Views: 3,274
 

 Orally inhaled products

Hello Priya,
Thanks so much for sharing your thoughts regarding the retention samples. Do you happen to know if there is a guidance for this particular (orally inhaled) products? I found the information that you mentioned in Handling and Retention of BA and BE Testing Samples, but only NASAL products are discussed there (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072869.pdf).

I also found the same information in the Budesonide Guidance from 2012 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM319977.pdf). However, this is for inhalation suspension.

Can you guide me to the specific documents for orally inhaled products in a form of HFA aerosol or DPI?


Your help is greatly appreciated.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
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