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  • 1.  Comparative dissolution requirement for L2 change of an approved ANDA

    Posted 08-Apr-2018 04:10

    Dear all, 

    We are proceeding to change the formulation of an approved ANDA  (L2 as per SUPAC - IR). It falls under 
    Case C: High Permeability, Low Solubility Drugs

    Multi-point dissolution profiles should be performed in water, 0.1 N HCl, and USP buffer media at pH 4.5, 6.5, and 7.5 (five separate profiles) for the proposed and currently accepted formulations.

    The Product have 04 different strengths. Now what should be the approach to perform comparative dissolution  - 

    1. accepted formulation  Vs proposed formulation of all the 04 different strength , in all the above pH media   

    2. BE strength (higher strength) -accepted formulation   Vs    Higher strength -  proposed formulation , along with 

    Higher strength (proposed ) Vs  across other strength (Proposed ) in all the pH media

    3.   accepted formulation of all strength Vs RLD of all strength , along with accepted (higher strength) Vs proposed higher strength, in all pH media 


    To my understanding , option -2 is sufficient to submit PAS.

    Please share your comments.  


    ------------------------------
    Mir Hossain PharmD
    Gulshan Model Town
    Bangladesh
    ------------------------------


  • 2.  RE: Comparative dissolution requirement for L2 change of an approved ANDA

    Posted 11-Apr-2018 12:44
    I believe following approach will satisfy the requirement of PAS;

    • Accepted formulation of all strength Vs RLD of all strength , along with accepted (higher strength) Vs proposed higher strength, in all pH media


    ------------------------------
    Pravin Rothe
    ------------------------------

    Original Message


  • 3.  RE: Comparative dissolution requirement for L2 change of an approved ANDA

    Posted 22-Apr-2018 00:10

    Hi, 

    Thank you for sharing your understanding. 

    Requirement for L2 changes ( SUPAC – IR ) for PAS : Multi-point dissolution profiles should be performed in water, 0.1 N HCl, and USP buffer media at pH 4.5, 6.5, and 7.5 for the proposed and currently accepted formulation. Based on that  below is the proposed action plan for 04 different strengths . 

    1. Generate dissolution data in all the 05 media mentioned in SUPAC for proposed (A, B, C, D ) vs accepted formulation (A' , B' , C' , D' ) : that is  A vs A', B vs B', C vs C', D vs D')


    2. Generate dissolution data in only QC media for proposed higher strength (A)  vs proposed other strengths( B, C & D) :

    A vs B,  A vs C & A vs D:


    3. Generate dissolution data in only QC media for proposed (A, B, C, D )  vs RLD  :  A Vs RLD -A , B Vs RLD- B , C Vs RLD-C & D Vs RLD- D

    Please suggest if you have alternative option.  

    Regards,

    ------------------------------
    Mir Hossain PharmD
    Gulshan Model Town
    Bangladesh
    ------------------------------

    Original Message


  • 4.  RE: Comparative dissolution requirement for L2 change of an approved ANDA
    Best Answer

    Posted 12-Apr-2018 12:41
    You already compared RLD vs approved formulation in initial submission, and agency has accepted the data.

    so, you can do no.1 option as far as RLD remains from the same company (NDA / ANDA) as you filed in initial submission.

    ------------------------------
    Gaurang Bhavsar, MS, RAC
    Manager, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
    ------------------------------

    Original Message


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