ReviewJournal of pharmaceutical sciences2026
Classification system proposed to guide the design, development, regulatory approval, and scaling of long acting, small- and macro-molecule parenteral products (CS-BLAP).
Review in Journal of pharmaceutical sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
Long acting (LA) drug products extend the effect of a single dose for weeks or months, offering new options for disease prevention and treatment. However, regulatory guidance on LA drug product development and equivalence remains limited. The existing Biopharmaceutics Classification System (BCS) guides the development and approval of small-molecule oral drug substances. There is no such classification system for LA drug products. Most LA drug products are given as subcutaneous (SC) or intramuscular (IM) injectables. We propose a new Classification System for Biopharmaceutics of Long-Acting Parenteral Products, designated as CS-BLAP. This classification system focuses on products instead of drug substances. CS-BLAP covers LA products beyond those based on conventional depot/sustained drug-release strategies and includes small- and macro-molecules (biologics) designed with or without delivery system and engineered to transit through lymph instead of directly penetrating the blood. We found that the molecular or particle size of drugs assembled as LA products is the basis of the classification in determining the route/mechanism of parenteral drug absorption. Depending on the product size, SC or IM injectables may preferentially penetrate blood or lymphatic capillaries. Based on their selectivity in lymph vs blood uptake, retention, and transit, LA products are classified as: Class I: Small molecules, absorption mainly via blood after release from depot products; Class II: Small molecules, absorption of drug-in-carrier via lymph;Class III: Biologics, absorption mainly via blood after release from depot products; Class IV: Biologics, absorption via lymph. The CS-BLAP proposal is supported by a dataset of drugs and endogenous molecules spanning a range of molecular weights and particle sizes. From these datasets, a predictive model estimated the lymph-to-blood absorption fraction as a function of apparent molecular size. The mid-transition point occurs around 35 kDa, where the drug substance (either free or associated with a delivery system) distributes equally between lymph and blood (50:50). Increasing molecular size progressively favor distribution through the lymphatic pathway, estimated to be 70 % at 50 kDa, 80 % at 66 kDa, and >90 % beyond 90 kDa. The time-to-peak plasma concentration (T
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